Fetch 2 Aspiration Catheter Recall Issued Due to Risk of Shaft Breakage
Boston Scientific is recalling more than 21,000 catheters used during medical procedures to remove blood clots from coronary arteries, after receiving several reports of the catheter shafts breaking during use, which may cause an artery blockage from device fragments.
The Fetch 2 Aspiration Catheter recall was announced by the FDA on April 8, following several reports from physicians indicating the shafts of the catheters broke during the procedures, posing an embolism and further clotting issues that could require immediate surgery to remove. To date, no injuries or deaths have been reported.
The recalled Fetch 2 Aspiration Catheters are used during procedures to remove small blood clots from the coronary arteries. In the event that a catheter shaft breaks during a procedure, it could allow fragments of the device to enter the arteries and cause an embolism, leading to the obstruction of blood flow or additional intervention to remove a device fragment surgically.
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There have been several reports of the catheters breaking during procedures. However, all of the reports indicate they were either removed immediately, while still partially attached, or retrieved with a snare without any further complications.
The recall was originally announced by the FDA on March 22, following reports of the catheters breaking, but has since been reclassified by the FDA as a Class I recall. Class I recalls are the most serious recalls and indicate that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.
At least 21,155 Fetch2 US catheters are included in the recall, with model number 109400-001, which were sold across the globe. Additional Fetch2 catheters that were sold outside of the United States include Fetch2 OUS with model number 109400-002, Fetch2 Canada with model number 109400-004, Fetch2 Japan with model number 109400-004 and Fetch2 EU with model number 109400-005.
The devices were manufactured under Bayer Medical Care Inc. between June 11, 2014, and February 19, 2016. They were later acquired by Boston Scientific as the products entered the market. Physicians and healthcare professionals should be aware that the product packaging and labeling will be marked with the Bayer Medical Care name brand.
Physicians and healthcare providers are being asked to stop using the recalled Fetch2 catheters immediately and return them to Boston Scientific. For further questions or concerns regarding returns, consumers may contact Boston Scientific at 1-800-811-3211.
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