Medtronic has sent a letter to hospitals and health care providers about potential manufacturing problems with Consulta and Syncra implantable pacemakers.
The devices, known as cardiac resynchronization therapy pacemakers (CRT-Ps) may have certain manufacturing defects, which could pose a potential risk for patients. However, there have been no injuries or adverse events reported in connection to the problem, according to the FDA.
“This issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of the connector bracket,” Medtronic wrote to its customers. “An out-of-specification weld could result in a loss of device hermeticity and compromise device functionality.”
The recall only affects non-implanted Consulta CRT-P Model C4TR01 and C3TR01 (not approved for use in the U.S.) and Syncra CRT-P Model C2TR01 devices manufactured between April 1 and May 13, 2013. The company made no recommendations regarding devices that have already been implanted in patients. The FDA announcement includes a full list of serial numbers of affected devices.
Medtronic is calling for the non-implanted devices affected by the recall to be returned for inspection. The company also wants implanted devices affected by the recall registered by calling the Medtronic Patient Registration Department at (800) 848-9300. Customers with questions can also call (763) 526-6000.