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Boston Scientific Recalls Angiographic Catheters Due to Injuries

Boston Scientific is recalling 6,130 Imager II 5F Angiographic Catheters because there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation. FDA had received nine injury reports for this product as of Tuesday.

Amanda Pedersen

April 7, 2020

1 Min Read
Boston Scientific Recalls Angiographic Catheters Due to Injuries
According to the recall notice from FDA, use of the affected product may lead to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital.Graphic by MD+DI/Amanda Pedersen

At least nine people have been injured by a faulty cateter tip on Boston Scientific's Imager II 5F Angiographic Catheters, FDA reported this week. The company initiated a recall of the device in February that includes 6,130 of the catheters distributed between July 16, 2018 and Nov. 26, 2019. Click here for a full list of affected lot numbers.

The catheters are used to provide a pathway to deliver contrast agents to blood vessels. FDA said there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation. According to the recall notice from FDA, use of the affected product may lead to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital. The agency said there is also the potential for serious adverse events including obstruction of blood flow (embolism), stroke, or death.

Customers have been asked to remove any affected lots in the hospital inventory, stop using product with the affected lot number, and return to the company. Customers who have questions about the notification should contact their local sales representative or [email protected].

About the Author(s)

Amanda Pedersen

Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.

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