Boston Scientific Innova Stent Recall Affects 505 Defective Devices

More than 500 Boston Scientific Innova stents have been recalled because some have failed to deploy properly when inserted into patients. 

The Boston Scientific stent recall was announced on June 16 by the FDA, which classified the market withdrawal as a Class 1 medical device recall. The classification means that the FDA believes the defective stents carry a reasonable probability of causing serious injury or death to a patient.

The stents are used in the femoral and proximal popliteal arteries to treat symptomatic de novo or restenotic lesions. The recall comes following complaints to Boston Scientific that some of the stents failed to deploy when implanted in patients or only partially deployed.

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If the stent fails to deploy properly it could cause damage to the vessel walls, call for more extensive implant surgery or even require emergency surgery to remove a badly deployed stent.

The stents are in the trial phase of testing in the United States and have not received FDA approval for commercial distribution yet. The stents gained approval for distribution in Europe in April. Boston Scientific warned customers outside of the U.S. of the problem in a letter in May.

The recall notice did not indicate whether there have been any injuries or deaths as a result of the defective Innova stents.

The recall affects Boston Scientific Innova Over-the-Wire Self-Expanding Stent Systems. A complete list of affected stents is listed in the recall notice. The recall does not affect stents that have already been successfully implanted into patients.

Health care professionals who have purchased the recalled stents are urged to immediately discontinue their use and return all affected products back to Boston Scientific. Customers with questions can call the Boston Scientific Maple Grove Complaint Call Center at 1-800-811-3211.


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