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| Fetch 2 Aspiration Catheter--Courtesy of Boston Scientific |
Boston Scientific ($BSX) is recalling all models of its Fetch 2 Aspiration Catheter. The recall of the thrombectomy catheter is due to shaft breakage complaints--and has been classified as Class I by the FDA, indicating that use of the device could result in serious adverse health consequences or death.
The company said it started the recall of the catheter on March 22. The Fetch 2 catheter is used in procedures to remove small blood clots from coronary arteries. The recall involves 21,155 devices manufactured between June 11, 2014, and Feb. 19, 2016.
"All reports of shaft breakage happened 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," Boston Scientific described in a statement.
It said that patients who have already undergone a thrombectomy with the device are not at risk and that there haven't been any reports of injury or death. But it added that the most "severe potential outcome" of breakage is that device fragments could obstruct an artery, thereby potentially obstructing blood flow and requiring additional surgical intervention for removal.
Boston Scientific asked all healthcare facilities to immediately discontinue use of Fetch 2 catheters and return them. The catheter was from the Boston Scientific acquisition of Bayer Interventional for $415 million that closed in August 2014. The Fetch 2 catheter is marketed under the Bayer brand.
- here is the Boston Scientific announcement