Boston Scientific has initiated a recall of Imager II Angiographic Catheters following identification of a manufacturing defect that may cause catheter tip detachment during clinical procedures. The FDA has classified this as a safety alert, with potential risks including procedural delays and embolism—a serious condition where detached material may lodge in blood vessels.
The recall affects angiographic catheters used in cardiac and vascular imaging procedures. Healthcare facilities currently using this device are advised to immediately review their inventory and cease use of affected units. The manufacturing issue requires verification before resumption of clinical deployment.
The FDA and Boston Scientific are coordinating the recall response. Medical institutions should consult the official FDA Medical Device Recalls database for lot numbers, serial information, and detailed guidance. Healthcare providers who have used this catheter should evaluate patient outcomes and report any adverse events to the FDA MedWatch program. This is a developing story.
Source: Angiographic Catheter Recall: Boston Scientific Removes Imager II Angiographic Catheters
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