Boston Scientific is reporting new problems with two defibrillator products. The company has major operations in Minnesota making the devices, that shock an abnormally beating heart back into rhythm.
The advisory to physicians concerns the Teligen and Cognis devices. Both have a breathing sensor that, if turned on, can lead to inappropriate shocks, if certain other problems are present in the wire that connects the device to the heart.
No deaths have been associated with the problem. So far there have been 15 reports of inappropriate shocks. The devices are implanted in about 8,000 people worldwide.
Boston Scientific has struggled to get past quality control concerns in some key products for the past several years.