FDA Flags Boston Scientific Catheter Recall as Class I Risk

Key Facts

Boston Scientific is recalling Imager II Angiographic Catheters due to a defect involving tip detachment. Benzinga reported that the FDA has flagged the recall as a Class I risk, the most serious category, because the manufacturing flaw could lead to patient injury if the device tip breaks off in the bloodstream.

BSX closed at $43.92 on September 25, 2026, with the stock reaching a day high of $44.84 and a low of $43.33 during that session. The regulatory action highlights ongoing safety oversight within the medical device sector regarding manufacturing standards.