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Medical devices are recalled when they have a problem that needs to be fixed or watched closely. The device may not work right, may be a health risk, or both.
A cardiac device—such as an implantable cardiac defibrillator (ICD), a pacemaker, or the leads that connect them—helps your heart beat steadily. If a cardiac device were to fail, it might not provide a shock when needed or keep your heart beating at a steady rhythm. But it's rare for cardiac devices to fail or be recalled.
A recall is usually issued by the maker of the device. But the U.S. Food and Drug Administration (FDA) also can recall devices.
A recall of a cardiac device does not mean that it needs to be removed. In most recalls, devices are watched closely or reprogrammed. Only a small number are removed.
The FDA has three levels—or classes—of recall, depending on the chance of a device failing and possibly hurting someone.1
The decision to remove the device depends on how likely it is that the device might fail or cause harm. Your doctor will consider which is more likely to happen: problems from surgery to replace the device, or the device failing.
The maker of the device would contact you if your device were recalled. Your doctor also might contact you.
You would meet with your doctor to talk about the problem and what to do. In most cases, your doctor would check the device often to make sure it's working right. Your doctor might need to reprogram the device.
If you read or hear about a recall and you're curious to know whether your device is affected, you can check the information on your device ID card. To be part of a recall, your device must match the recalled device in ALL of these areas:
Call your doctor if:
U.S. Food and Drug Administration (2010). Recalls, corrections and removals (devices). Available online: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/default.htm.
Other Works Consulted
Kalahasty G, Ellenbogen KA (2011). Management of the patient with implantable cardioverter-defibrillator lead failure. Circulation, 123(12): 1352–1354.
Kirian KB, et al. (2009). How to respond to an implantable cardioverter-defibrillator recall. Circulation, 119(5): e189–e191.
Maisel WH, et al. (2009). Recommendations from the Heart Rhythm Society Task Force on Lead Performance Policies and Guidelines: Developed in collaboration with the American College of Cardiology (ACC) and the American Heart Association (AHA). Heart Rhythm, 6(6): 869–885.
June 12, 2013
E. Gregory Thompson, MD - Internal Medicine & Rakesh K. Pai, MD, FACC - Cardiology, Electrophysiology
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