US based Medtronic has sent an urgent medical device recall notice to customers after becoming aware of a manufacturing defect.
The recalled products are the Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs). The US Food and Drug Administration (FDA) has identified this as a Class 1 recall, on the basis that use of these devices may cause serious injuries or death.
The defibrillators provide pacing for slow heart rhythms and electrical shocks or pacing to stop dangerously fast heart rhythms. They are both implanted under the skin in the upper chest area with connecting insulated wires called "leads" that go into the heart.
The defect causes an out of specification gas mixture inside devices that may prevent the defibrillators from delivering the life-saving, electric shock therapies patients need to pace their heartbeat or revive those in cardiac arrest.
A spokesperson for Medtronic has advised that the manufacturing processes have been updated to prevent the specific sequence associated with this issue from occurring.
Elise Bevan, senior associate in the product liability team at Penningtons Manches, said: “It is understood that 48 patients have been fitted with affected devices and all of them have been notified. Due to the nature of the issue, however, it is not possible to identify which of the 48 devices may fail or when they may fail. Medtronic has advised surgeons to consider removing the devices while the FDA is telling healthcare professionals and patients to report adverse events or side effects related to the use of these products to its MedWatch Safety Information and Adverse Event Reporting Program. It is not known at this stage whether any of the affected patients are based in the UK.”