A number of Medtronic heart implants are being recalled due to a defect that may prevent them from providing life-saving shocks, potentially resulting in patient deaths.
The Medtronic recall impacts certain Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs), which are supposed to help regulate the pace of slow heart rhythms and provide electrical shocks or pacing to dangerously fast heart rhythms.
On February 26, the FDA classified this action as a Class I recall, meaning that the agency believes problems with these devices could result in severe injury or death.
Medtronic indicates that the recall was issued due to a manufacturing defect, which can cause an “out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.”
The recall does not indicate whether there have been any injuries or deaths linked to the ICD and CRT-D defects.
The company first notified affected customers in a January 22 Urgent Medical Device Recall Notice. The notice recommends that health care professionals consider a prophylactic device replacement for patients implanted with one of the affected units. It also recommends that customers contact Medtronic sales representatives for terms and conditions for device warranties, and ensure that the appropriate health care staff are aware of the recall.
The recall affects Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) with product codes NIK and LWS. The affected devices were manufactured from July 13, 2013 to August 8, 2017. A complete list of affected serial numbers is listed in the FDA recall notice linked above.
Customers with questions or who need additional information can contact their Medtronic sales representative or Medtronic Technical Services by calling 800-723-4636. Patients with questions can contact Medtronic Patient Services by calling 800-551-5544.
Health care providers or patients who have experienced adverse health effects or problems linked to the recalled Medtronic heart implants are urged to file a report with the FDA MedWatch adverse event reporting system.