Shaft Breakage Risk Prompts Catheter Recall from Boston Scientific

Shaft Breakage Risk Prompts Catheter Recall from Boston Scientific
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April 11, 2016

Boston Scientific has announced a recall for a potentially dangerous medical device.

The company is voluntarily recalling all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The recall is being made after consumer complaints of shaft breakage. About 21,000 devices are included.

The product bears Universal Product Number (UPN) 109400-001. Since Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care, all recalled inventory is packaged and labeled as Bayer product.

There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter.

All reports of incidents occurred during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications.

The Food and Drug Administration (FDA) has classified this action as a Class 1 recall. This means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.

Customers and healthcare professionals with questions about this recall can contact Boston Scientific at (800) 811-3211.