St. Jude Medical is recalling its Optisure dual coil defibrillation leads due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils.
The recall, designated as Class 1 by the FDA, involves 447 devices manufactured from March 12, 2014 to March 22, 2015, and distributed from April 9, 2014 to Oct. 20, 2015.
An investigation revealed that a variation in the process to remove excess medical adhesive used in the assembly of the superior vena cava shock coil could result in cuts to the insulation of the lead, potentially causing an electrical malfunction. However, the company says there is a low probability for this problem and that any associated risks can be prevented with device reprogramming.
“Depending on device programming and the depth of the cut, this could result in the inability of the defibrillator to deliver electrical therapy to the patient,” says the FDA’s notice.
The use of affected products may cause serious adverse health consequences, including patient injury or death. However, St. Jude says it has received no reports of lead malfunction or patient injury.
The company’s original advisory stated that 281 of the devices were distributed in the U.S. Since issuing its “Dear Doctor” letter in November 2015, St. Jude Medical clarified with the FDA that three of the leads were never implanted in patients, bringing the total U.S. population of implanted leads to 278, company spokesman Justin Paquette tells IDDM.
In addition to the U.S., the devices were distributed in Belgium, Switzerland, Germany, France, the UK, India, Italy, Japan, Luxembourg, the Netherlands, Saudi Arabia and Sweden.