TITLE: My Pacemaker Was Recalled — Do I Have a Medical Negligence Claim in Australia?
You trusted a device that was supposed to keep your heart beating
Finding out that the pacemaker inside your chest has been recalled — or that the manufacturer has withdrawn it from the market — is a particular kind of shock. It is not like being told a medication has a new warning label. This is a device that was surgically implanted in your body, that you were told was safe, and that you have been living with, often for years.
Many people in this situation feel a quiet, persistent dread: Is it still working properly? Should I have been told sooner? Did my cardiologist know and not say anything? Those are not irrational fears. They are the right questions.
This article is for people who have a Medtronic Accolade MRI pacemaker — or another recalled or withdrawn cardiac device — implanted in Australia, and who want to understand what they were entitled to, what may have gone wrong, and whether the law offers them any recourse. By the end, you will have a clearer picture of who bears responsibility, what harm is legally recognised, and what your next step might be.
What you were entitled to — the standard of care around implanted devices
When a cardiac device is implanted in Australia, the obligations on the people involved do not end when the wound closes. The cardiologist, the hospital, and — through the regulatory system — the manufacturer each carry ongoing duties.
What it requires: Manufacturers and sponsors of medical devices must report serious adverse events and initiate recalls when a device presents an unacceptable risk. Treating clinicians and hospitals are required to participate in recall processes and to notify affected patients in a timely way once a recall or hazard alert is issued.
Why this matters: There is often a significant gap between when a safety signal is identified, when the TGA acts, and when individual patients are actually told — and that gap can cause real harm.
Beyond the regulatory framework, your cardiologist owed you a continuing duty of care. That duty included monitoring your device, staying current with safety communications from the manufacturer and the TGA, and telling you — promptly and clearly — if a concern arose about the device in your chest. Healthdirect Australia provides general information about pacemaker monitoring and follow-up that reflects what routine care should look like.
A woman in her late sixties had a pacemaker implanted after a diagnosis of sick sinus syndrome. She attended annual device checks at her cardiologist’s rooms and was told each time that everything looked fine. Eighteen months after a safety advisory was issued about her device model, she read about it in a newspaper. When she called her cardiologist’s rooms, the receptionist said they would “look into it.” She had never received a letter, a phone call, or any direct communication. She spent the following weeks sleeping poorly, afraid to exercise, and unsure whether the device keeping her heart in rhythm was reliable.
Where the system fails — and why it keeps failing
The manufacturer does not tell patients directly
A retired teacher had a Medtronic Accolade MRI pacemaker implanted in 2019. When Medtronic issued communications to hospitals and cardiologists about concerns with the device’s MRI conditional labelling and certain performance parameters, those communications went to the implanting institution — not to him. His GP had not been copied in. His cardiologist was at a large private practice that had seen hundreds of device patients. His letter, if it was ever sent, never arrived. He found out about the withdrawal when a family member searched online after he mentioned chest discomfort at Christmas dinner.
In Australia, the TGA’s recall and hazard alert system is primarily directed at manufacturers, sponsors, hospitals, and clinicians — not at individual patients. The manufacturer’s legal obligation is to notify the TGA and the supply chain. What happens after that — whether the cardiologist contacts the patient, whether the hospital has a recall register, whether the GP is looped in — is inconsistent and largely unregulated at the patient-contact level.
This is a structural failure. It is not unique to any one manufacturer or device. But it means that patients with implanted devices are routinely the last to know when something is wrong with what is inside them.
The implanting cardiologist does not follow up
Once a TGA hazard alert or recall notice is issued, the implanting cardiologist — and the hospital where the device was implanted — have a clear professional and legal obligation to identify affected patients and contact them. The Medical Board of Australia’s Good Medical Practice guidelines require doctors to act promptly when patient safety is at risk. Failing to maintain a device registry, failing to cross-reference a recall notice against that registry, or simply not prioritising the follow-up calls is a failure of that duty.
In busy cardiology practices, device recalls can be treated as administrative tasks rather than clinical emergencies. A letter may be drafted but not sent. A recall register may not exist. A locum may not know which patients have which devices. These are not excuses — they are the conditions under which patients are harmed.
The GP is not told and cannot act
Many patients with pacemakers see their GP far more regularly than their cardiologist. If the GP is not notified of a device recall — and in most cases they are not — they cannot counsel the patient, arrange urgent review, or document the concern in the patient’s record. The GP’s duty of care does not extend to knowing about every device recall, but if they are aware of a concern and fail to act, that changes.
The more common failure is systemic: the GP is simply not in the information loop, and the patient falls through the gap between the cardiologist’s recall process and the primary care system.
Consent at implant did not cover this risk
When a pacemaker is implanted, patients are counselled about the risks of the procedure — infection, lead dislodgement, bleeding. They are rarely told in any meaningful way about the possibility that the device itself might be recalled, withdrawn, or found to have a manufacturing defect after implantation. The consent process does not typically address what happens if the device is later found to be unsafe.
This matters legally. If you were not told that device withdrawal was a known possibility — and that it might require revision surgery, additional monitoring, or a period of living with an unreliable device — then the consent you gave was incomplete.
What happened: A patient suffered harm following a cardiac procedure. The question before the court was whether the treating doctor had adequately warned the patient of the risks involved and whether the failure to warn caused the harm that followed.
What the court found: The court confirmed that the duty to warn is not discharged by a general conversation — it requires that the patient be given information that a reasonable person in their position would want to know, in a form they can actually understand and act on.
Why this matters: If you were not told about the possibility of device recall or withdrawal at the time of implant, or were not contacted promptly when a recall occurred, this principle supports the argument that your right to make informed decisions about your own care was not respected.
For broader context on how Australian hospitals are required to manage patient safety events, including device recalls, see the Australian Commission on Safety and Quality in Health Care.
What your situation might mean
If you had a Medtronic Accolade MRI pacemaker implanted and were never contacted when the device was withdrawn from the market, you were not given the information you needed to make decisions about your own health. Whether that silence gives rise to a legal claim depends on what happened next — but the silence itself is not acceptable, and it is not something you simply have to accept.
If you experienced symptoms — dizziness, palpitations, syncope, shortness of breath — during the period when your device was under a safety advisory and your cardiologist did not connect those symptoms to the device concern, that is a different and more serious failure. A clinician who is aware of a device recall and does not consider it as a possible explanation for new cardiac symptoms may have fallen below the standard of care.
If you required revision surgery — having the device explanted and replaced — because of the recall, the question is whether that surgery was caused by the device failure, by the delay in notification, or by both. The costs of that surgery, the recovery period, the anaesthetic risk, and the psychological impact of going back under the knife are all potentially recoverable.
If you were told about the recall but were not given a clear management plan — no enhanced monitoring, no explanation of what to watch for, no documented follow-up — then the notification, even if it happened, may not have been adequate. Being told something is recalled without being told what to do about it is not the same as being properly cared for.
The legal picture
In Australia, liability for a recalled or defective implanted device can sit with several parties at once. The manufacturer — in this case Medtronic — may be liable under the Australian Consumer Law for supplying a product with a safety defect. The implanting cardiologist may be liable in negligence for failing to notify you, failing to monitor your device in light of the recall, or failing to obtain proper informed consent at the time of implant. The hospital where the device was implanted may be liable for failing to maintain an adequate device register or recall response system. Your GP may bear some responsibility if they were aware of a concern and did not act.
Australian negligence law requires that a duty of care existed, that the standard of care was not met, and that the failure caused you harm you would not otherwise have suffered. A bad outcome from a device that was properly implanted, properly monitored, and properly recalled is not necessarily negligence. But a bad outcome — or a period of unreasonable risk — caused by a failure to notify, a failure to monitor, or a failure to act on a known safety concern is a different matter entirely.
For more on how these claims are assessed, see Reframe Legal — Medical Negligence.
General educational framework only. Every case depends on its own facts.
The harm that follows a recalled pacemaker
The physical consequences of a recalled or withdrawn pacemaker depend on what the device was recalled for and how long the patient went without appropriate management. For the Accolade MRI device, concerns related to specific performance parameters mean that some patients may have experienced inappropriate pacing behaviour, failure to pace on demand, or uncertainty about MRI compatibility that led to necessary imaging being delayed or avoided.
In the short term, patients may experience palpitations, dizziness, syncope, or breathlessness — symptoms that are frightening and that may not be immediately connected to the device. In the longer term, inadequate pacing can contribute to heart failure progression, falls and injury from syncope, and the need for revision surgery that carries its own risks: infection, lead complications, anaesthetic risk, and recovery time that is significant for older patients.
The psychological harm is real and often underestimated. Living with a device that has been recalled — particularly when you were not told about it promptly — produces a specific kind of anxiety. Every flutter, every moment of light-headedness, becomes a question: Is it the pacemaker? Research on patients with recalled cardiac devices consistently documents elevated rates of anxiety, depression, and health-related quality of life impairment that persist well beyond the resolution of the device issue itself.
The financial consequences include the cost of additional cardiology appointments, the cost of revision surgery if required, lost income during recovery, and in some cases the cost of private treatment sought because the patient could not get timely answers through the public system.
What compensation covers
If a claim succeeds, compensation in Australian medical negligence cases can cover the costs of additional treatment — including revision surgery, rehabilitation, and ongoing cardiology care. It can cover lost income if you were unable to work during recovery. It can cover the cost of care provided by a family member. And it can cover general damages for pain, suffering, and loss of enjoyment of life — including the psychological harm of living with a recalled device and the anxiety that follows.
In most Australian states, there is a threshold of injury severity that must be met before general damages (pain and suffering) are recoverable. For cardiac device cases involving revision surgery or a documented period of significant psychological harm, that threshold is often met. Time limits for bringing a claim are generally three years from the date you knew — or ought reasonably to have known — that you had suffered harm as a result of a failure of care. For recalled device cases, the discovery rule is important: the clock may not start until you actually found out about the recall and its consequences.
| Severity of harm | Indicative range (Australia) | What this covers |
|---|---|---|
| Moderate injury with recovery | $50,000–$150,000 | Treatment costs, time off work, pain and disruption |
| Serious injury with lasting effects | $150,000–$500,000 | Permanent impairment, ongoing treatment, care needs |
| Severe or life-changing injury | $500,000–$2,000,000+ | Catastrophic loss of function, lifetime care, lost earning capacity |
General reference ranges only. Every case turns on its own evidence.
For more detail on how these claims proceed in practice, see Reframe Legal — How Medical Negligence Claims Work in Australia.
Was it avoidable?
The question underneath everything you have read is the one you have probably been sitting with since you found out: should I have been told sooner, and would it have made a difference?
What the medical records will show — the device implant report, the follow-up notes, the TGA recall date, the date of any letter sent to you — is objective. It does not depend on anyone’s memory or goodwill. Those records will either show that you were contacted promptly and given a proper management plan, or they will show that you were not. That is the starting point for any honest assessment of your situation.
Many people in this situation wait a long time before asking these questions. They do not want to seem ungrateful for the care they received. They are not sure whether what happened to them was unusual. They assume that if something had really gone wrong, someone would have told them. That instinct is understandable — but the question does not go away, and waiting does not make it easier to answer.
If you were not given proper information about the risks of the device at the time of implant, the principles around informed consent and medical negligence are directly relevant to your situation. You can also check whether your treating practitioners are registered and in good standing through AHPRA — the Australian Health Practitioner Regulation Agency.
About Dr Rosemary Listing
Dr Rosemary Listing is a medical negligence lawyer with a background in medicine. She practises in Australia, acting for patients and families who have been harmed by failures in medical care. Her work spans surgical errors, diagnostic failures, medication harm, and — increasingly — cases involving recalled or defective implanted medical devices.
Cases involving recalled pacemakers and other cardiac devices are legally complex in ways that are not obvious from the outside. Liability can sit with the manufacturer, the implanting cardiologist, the hospital, or all three simultaneously. The regulatory framework — the TGA recall system, the Australian Consumer Law, and the common law of negligence — operates in parallel, and navigating all three requires both clinical and legal understanding. Patients are rarely in a position to see this complexity from inside their own experience.
Most people who come to Dr Listing with a recalled device question have been sitting with it for a long time. They are not angry people looking for someone to blame. They are people who trusted the healthcare system, who did everything they were asked to do, and who want an honest answer to a reasonable question: was what happened to me avoidable, and does it matter?
Dr Listing examines the medical records alongside independent expert clinical opinion to give that honest answer. Sometimes the answer is that what happened was an acceptable risk of a necessary procedure. Sometimes it is that the failure to notify, monitor, or act was a breach of the standard of care that caused real and compensable harm. Either way, the person asking deserves to know.
- Therapeutic Goods Administration (TGA), Annual Performance Statistics 2022–23, Australian Government Department of Health and Aged Care, Canberra, 2023.
- TGA, Database of Adverse Event Notifications (DAEN) — Medical Devices, available at tga.gov.au.
- TGA, Recall and Hazard Alert Database, including records relating to Medtronic Accolade MRI pacemaker, available at tga.gov.au/recalls.
- Therapeutic Goods Act 1989 (Cth), ss 41MA–41MN (mandatory reporting and recall obligations for medical devices).
- Australian Consumer Law (Competition and Consumer Act 2010 (Cth), Sch 2), ss 138–141 (liability for goods with safety defects).
- Medical Board of Australia, Good Medical Practice: A Code of Conduct for Doctors in Australia, 2020, paras 3.4, 3.10 (duty to act on patient safety concerns).
- Australian Commission on Safety and Quality in Health Care, National Safety and Quality Health Service Standards, 2nd ed, 2017, Standard 1 (Clinical Governance), Standard 6 (Communicating for Safety).
- Dobler v Halverson [2007] NSWCA 335 (duty to warn; causation in cardiac procedure cases).
- Rogers v Whitaker (1992) 175 CLR 479 (High Court of Australia — foundational authority on informed consent and the duty to warn).
- Civil Liability Act 2002 (NSW), ss 5B, 5D, 5E (negligence, causation, and harm); equivalent provisions in other Australian jurisdictions.
- Sears SF et al, “The psychosocial impact of implantable cardioverter defibrillators and pacemaker recalls” (2006) 3(4) Nature Clinical Practice Cardiovascular Medicine 690–697 (psychological harm in recalled device patients).
- Senate Community Affairs References Committee, Poorly Performing Medical Devices, Parliament of Australia, 2020 (systemic failures in Australian device recall notification).
- Healthdirect Australia, Pacemakers, available at healthdirect.gov.au.
This article contains general legal information only. It does not constitute legal advice, and reading it does not create a lawyer–client relationship. The law discussed applies to Australia. Laws and time limits vary between states and territories. You should seek independent legal advice about your specific situation.