St. Jude Medical announced on Jan. 22 that the FDA had classified a previous voluntary recall of the company's Optisure dual coil defibrillation leads as a Class 1 device recall.
On Nov. 3, 2015, St. Jude Medical sent an advisory letter to doctors alerting them of issues with 447 Optisure leads, including 278 that were distributed in the U.S.
St. Jude Medical found that “during the manufacturing process of a limited number of Optisure leads, a trim technique to remove excess medical adhesive around the SVC shock coil may have introduced damage to the lead’s insulation,” according to an FDA notice.
There were no reports of lead malfunction or patient injury related to the issue, according to a St. Jude Medical news release.
The Optisure leads are used in conjunction with implantable cardioverter defibrillators. The leads were distributed in the U.S., Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, The Netherlands, Saudi Arabia and Sweden.
“A St. Jude Medical internal investigation found the probability that a lead was damaged as a result of the manufacturing variation to an extent that it could result in the inability to deliver appropriate high voltage therapy is very low and that any associated risks can be prevented with device reprogramming,” the company said in a news release. “The patients’ leads can also be monitored from home using the Merlin.net remote care system. The company has not received any reports of compromised performance of the impacted Optisure leads. St. Jude Medical is in the process of providing an updated advisory notice to physicians to further ensure physicians are aware of recommendations for managing their patients who may have been implanted with the impacted leads.”