Manufacturing Defect Leads to Recall of Implanted Medtronic CRT-D Devices, ICDs
The company is advising physicians to consider explanting the affected devices, used in 48 patients in the United States.
A manufacturing defect that prevents delivery of necessary electrical shocks has resulted in the recall of four dozen already-implanted cardiac resynchronization therapy-defibrillation (CRT-D) devices and implantable cardioverter-defibrillators (ICDs) made by Medtronic.
The problem “causes an out-of-specification gas mixture inside the device” that prevents it from working properly, according to an announcement from the US Food and Drug Administration (FDA), which classified the move as a Class I recall, the most serious type.
Medtronic sent an Urgent Medical Device Recall notice to affected customers on January 22, 2018, advising physicians to strongly consider explanting the 48 affected devices, which were manufactured between July 13, 2013, and August 8, 2017. The serial numbers of the affected CRT-D devices and ICDs can be found in the FDA’s announcement.
A company spokesperson told TCTMD in an email that there have been no patient deaths related to the issue. There has been one confirmed device failure in which the device lost functionality, requiring external defibrillation to rescue the patient.
“Manufacturing processes have been updated to prevent the specific manufacturing sequence associated with this issue from occurring,” the spokesperson said.
Photo Credit: Medtronic.
FDA. Medtronic recalls cardiac resynchronization therapy and implantable cardioverter-defibrillators due to manufacturing error preventing electrical shock delivery. Published and Accessed on: February 26, 2018.