Medical device company Medtronic is recalling certain Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) due to a defect in the manufacturing process that causes an out-of-specification gas mixture inside the device, which may prevent it from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. A delay or inability to deliver a shock in these cases could result in serious injury and/or death.
ICDs and CRT-Ds are medical devices that provide pacing for slow heart rhythms, and electrical shock or pace to stop dangerously fast heart rhythms. Both ICDs and CRT-Ds are implanted under the skin in the upper chest area with connecting insulated wires, called leads, that go into the heart. Patients with heartbeats that are too slow (bradycardia) or too fast (tachycardia), or need coordination to treat heart failure may receive an ICD or CRT-D.
Patients who have affected devices should be aware that Medtronic is advising medical professionals to consider prophylactic device replacement for patients who have been implanted with a device that falls within this recall. Patients or caregivers should contact their doctors with any questions or to find out if their heart defibrillator is affected by the recall.
Any adverse events related to Medtronic ICDs and CRT-Ds should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice