Boston Scientific recalls certain batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. Affected units have specific batch numbers and expiration dates. Consumers should check their product details to determine if they are affected.
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Boston Scientific is recalling specific batches of MAMBA Flex 135 Microcatheters because they were incorrectly labeled and packaged. This issue does not pose a safety risk but requires correction to ensure proper use and documentation.
The microcatheters were packaged with incorrect labels and a missing closure strip, which could lead to confusion during medical procedures. However, this does not cause immediate harm or injury.
Healthcare professionals who use these microcatheters in medical procedures may be affected. Patients using these devices are not directly impacted by the labeling issue.
Check for batch numbers 26578463 or 26578470 on the carton. The product was sold with an expiration date of January 4, 2023, and is labeled with a green color code.
Identify the batch number on the carton to determine if your microcatheter is affected.
No, the recall is for incorrect labeling and packaging, which does not pose a safety risk but requires correction for proper use.
Batch numbers 26578463 and 26578470 are affected.
Check the carton for batch numbers 26578463 or 26578470 and an expiration date of January 4, 2023.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1429-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1429-2021 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.
