Boston Scientific recalls Flexima Duodenal Bend Biliary Stent with Delivery System due to potential packaging seal defects. Affected units include specific model and lot numbers. Consumers should contact for details.
The sterile barrier may contain packaging seal defects.
Boston Scientific is recalling a specific type of biliary stent due to possible packaging seal defects. This could lead to contamination during use, though the risk is not described as causing serious injury in normal use.
The sterile barrier packaging may have seal defects, potentially allowing contamination of the stent. This could lead to infection or other complications if the stent is used without proper sterility.
Patients who received the Flexima Duodenal Bend Biliary Stent with Delivery System, model 7F (2.3mm) x7cm, Lot 22960201. Medical professionals using this device for procedures are most at risk.
Check for the model number 7F (2.3mm) x7cm and lot number 22960201 on the packaging. The product is sold under Boston Scientific Corporation.
Reach out to Boston Scientific for specific instructions on whether the stent is affected and what to do next.
The recall states potential packaging seal defects could lead to contamination, but the risk is not described as causing serious injury in normal use.
Look for the model number 7F (2.3mm) x7cm and lot number 22960201 on the packaging.
Contact Boston Scientific for specific instructions on whether the stent is affected and what to do next.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1013-2019 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1013-2019 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.
