The FDA has issued a safety alert for several models of Boston Scientific’s Endotak Reliance defibrillation leads after identifying a serious defect linked to 16 deaths and 386 injuries.
The leads, used in implantable defibrillators to deliver life-saving shocks during cardiac arrest, can become less effective over time due to calcification and tissue growth around the shock coils. This could block or weaken the electrical shock, potentially causing the device to fail during a cardiac emergency, according to a Sept. 12 news release from the FDA.
The issue affects specific models with ePTFE-coated coils and, in some cases, the issue may not show up until the device has been implanted for eight years or more.
Instead of removing the devices from use, Boston Scientific instructed healthcare providers to monitor affected patients closely and consider replacing the leads if the impedance is too high. The devicemaker also recommended reprogramming the defibrillators to reduce risk of failure.
