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10 Biggest Medical Device Recalls of 2016—Boston Scientific

Boston Scientific

Boston Scientific

Device: Certain lots of the Fetch 2 Aspiration Catheter, model number 109400-001. Click here for affected lot numbers.

Recall reason: According to information on the FDA recall page, "the catheter shaft may break at various points along the device . . . If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death."

When recall was initiated: March 22, 2016

Number of U.S. units impacted: 17,455 units

For more information, visit the FDA Recall page.



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