Boston Scientific recalls Flexima APDL Drainage Catheter Systems with specific material numbers due to potential holes in sterile barrier affecting device sterility. Affected units include model REF M001271960 and REF M001271970.
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility.
Boston Scientific is recalling Flexima APDL Drainage Catheter Systems with specific material numbers because the sterile barrier pouch might develop holes, risking contamination. This could lead to infections or other complications during medical procedures.
The sterile barrier pouch could develop holes, which might compromise the device's sterility. This increases the risk of infection or contamination during medical procedures if the device is not properly sterilized.
Patients receiving drainage catheter procedures and healthcare providers using these devices are most at risk. The recall affects specific model numbers sold in the U.S. between 2020 and 2027.
Check for material numbers REF M001271960 or REF M001271970 on the packaging. These units were sold with specific expiration dates between February 2021 and March 2027.
Look for material numbers REF M001271960 or REF M001271970 on the packaging or label.
The recall includes material numbers REF M001271960 and REF M001271970.
Check the packaging for material numbers REF M001271960 or REF M001271970. These units were sold with specific expiration dates between February 2021 and March 2027.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3147-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3147-2024 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.
