FDA: St. Jude Medical’s Optisure recall is Class I

The FDA termed a recall by St. Jude Medical (NYSE:STJ) of a small number of its Optisure defibrillator leads as Class I, denoting the risk of serious injury or death.

Little Canada, Minn.-based St. Jude notified physicians in a Nov. 3, 2015, letter that a technique used to strip adhesive from the Optisure’s superior vena cava shock coil could inadvertently damage the lead’s insulation, the FDA said. Of the 447 implantable cardioverter defibrillator leads affected, 281 were distributed in the U.S. and rest in Belgium, Switzerland, Germany, France, United Kingdom, India, Italy, Japan, Luxembourg, Holland, Saudi Arabia, and Sweden, according to the federal safety watchdog.

St. Jude (which claimed 278 Optisure leads were distributed in the U.S.) said it received no reports of lead malfunction or patient injury related to the problem. The probability that the issue will result in failure to deliver therapy is “very low” and “any associated risks can be prevented with device reprogramming,” the company said.

Most of the implanted Optisure leads were connected to ICDs with St. Jude’s DynamicTx feature “that provides additional protection to help ensure delivery of appropriate high voltage therapy even in the case of a compromised lead,” according to St. Jude. Doctors for the 9 patients with ICDs lacking the DynamicTX feature were advised to make sure the patients are enrolled in St. Jude’s Merlin.net monitoring network. Where appropriate, high-voltage testing or turning off the SVC coil should be considered for those patients,” the company said.

Patient safety is St. Jude Medical’s highest priority, and the company will continue to work closely with customers and global regulatory agencies to ensure effective communication to our physician partners. The company has alerted all physician customers impacted by the advisory by letter and all leads subject to this advisory have been accounted for and none remain in any field distribution,” St. Jude said.

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