Investigators continue to probe a Medtronic plant that manufactured a small number of implantable defibrillators with a potentially serious problem, warning letters released last week by the Food and Drug Administration show.
The manufacturing problems at the plant in Juncos, Puerto Rico, that led to the recall happened in the months after Hurricane Maria’s devastating sweep across the island last year, but a Medtronic spokeswoman said the issues were not storm-related.
In January, Medtronic sent out its first alerts to doctors and hospitals saying that 48 advanced Puerto Rican-made implantable defibrillators had a potential problem with electric arcing inside the device, and doctors should strongly consider removing them from some patients’ chests.
Hundreds of other defibrillators affected by the same issue were pulled out of stockrooms and returned to Medtronic.
In total, the recall affected 951 devices, making it one of the smaller voluntary actions among recent heart device recalls. No one was killed or injured, and there was one recorded “field failure” of a device that led to
