Class I Recall Issued for Defective St. Jude Device

St. Jude Medical, one of the largest medical device manufacturers in the world, has been hit with a recall by the Food & Drug Administration. The FDA is recalling nearly 450 cables produced by St. Jude that may have suffered damage in manufacturing. The product in question, Optisure dual coil defibrillation leads, were implanted into patients to help control irregular heartbeats.

Proactive Action By Both Parties

The recall was issued on Friday, January 22, and follows a voluntary action taken by St. Jude themselves. To date, neither the agency nor St. Jude has had any reports of injury or malfunction related to the cables. The FDA clearly believes a danger exists, however, as Class I is the most stringent form of recall. The FDA defines a Class I recall as:

“a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The issue with the cables involved damaged insulation, which in turn could cause an electrical malfunction. This would prevent the attached defibrillator from sending the correct voltage through the leads. Thankfully, nearly all of the patients with compromised cables have additional safety devices to ensure proper performance.

Defective Manufacturing

Fortunately, no one has yet been injured by this device, and the action taken by both St. Jude and the FDA should help prevent any such injuries. If an individual did suffer serious injury due to this dangerous medical device, however, they would have strong grounds for a product liability claim.

This case would come down to the issue of defective manufacturing. While the design of the device itself is considered to be relatively safe, errors made during the manufacturing process compromised this safety. This would hardly be the first such suit, as St. Jude is continuing to face litigation related to another defective defibrillator.

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If you or a loved one have been injured by a defective medical device or other defective product, call our firm today. Our Los Angeles product liability attorneys are dedicated to the pursuit of justice, and have successfully recovered numerous multi-million dollar verdicts and settlements on behalf of our clients.

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