Boston Scientific recalls 5F Angiographic Catheters with potential tip detachment. Affected units include specific material numbers from lots 1-94. Consumers should stop using these catheters immediately.
Potential for tip detachment of Imager II 5F Angiographic Catheters
Boston Scientific is recalling 5F Angiographic Catheters that could detach at the tip during use. This hazard may cause injury if the detached tip becomes lodged in a blood vessel. The recall covers specific material numbers across multiple lots.
The catheter tip may detach during medical procedures, potentially becoming lodged in blood vessels. This could cause serious injury or complications if the detached tip is not properly managed.
Healthcare professionals who use these catheters for medical procedures are most at risk. Patients receiving procedures with the recalled catheters could be affected if the tip detaches.
Check for the Material Number (UPN) Outer Package codes listed in the recall notice. The affected catheters come in packages with specific material numbers from the list provided in the recall.
Discontinue use of the recalled Imager II 5F Angiographic Catheters as they may detach at the tip during medical procedures.
The recall includes 5 units per package across 94 specific material numbers.
The catheter tip may detach during use, potentially becoming lodged in blood vessels and causing injury.
Check the Material Number (UPN) Outer Package codes listed in the recall notice. Affected units include specific material numbers from the list provided.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1555-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1555-2020 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
