Feb. 28 (UPI) — Medtronic has recalled 48 implantable and cardiac resynchronization defibrillators that are failing to deliver the proper shock to pace a patient’s heartbeat or revive a patient in cardiac arrest, the Food & Drug Administration announced.
The devices, similar to pacemakers that help the heart beat in a regular rhythm, are designed to prevent death from a cardiac arrest, according to the American Heart Association.
“The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death,” the FDA said in a press release.
An ICD, according to the company, is a battery-powered device placed under the skin that keeps track of your heart rate. Thin wires connect the ICD to your heart. If an abnormal heart rhythm is detected the device will deliver an electric shock to restore a normal heartbeat.
A CRT-D, which is like an ICD, is designed to stop life-threatening ventricular tachycardia and fibrillation with stimulation therapy or electrical shocks.
The FDA said the Class I recall was spurred by a defect that causes an out of specification gas mixture inside the device and may prevent it from delivering the electrical shock needed.
The products were manufactured between July 13, 2013 and Aug. 8, 2017. Affected are Amplia, Claria, Compia and Viva lines of CRT-Ds and a number of types of Evera and Visia ICDs. The specific serial numbers are listed on the FDA’s recall notice.
On Jan. 22, before the FDA issued its recall, Medtronic sent an “Urgent Medical Device Recall notice” to affected customers.
The company has asked medical professionals to consider prophylactic device replacements for patients who have been implanted with one of the affected devices. Medtronic said it will offer a supplemental device warranty for the affected devices.
The FDA is advising healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.
Medtronic, founded in 1949, is among the largest medical device companies in the world and has operational headquarters in Fridley, Minn.
The number of recalls and advisories of similar devices has increased over the past three decades, according to previous research by the National Institutes of Health, but “no consensus exists on how to best manage patients with these CIEDs partially because rates of complications from prophylactic replacement are unknown.”
Prophylactic replacement involves surgery to take out the affected device and insert a new one.