Boston Scientific recalls two models of Extractor Pro RX Retrieval Balloon Catheter due to incorrect labeling of the skive hole position. This could lead to improper use during medical procedures.
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Boston Scientific is recalling two specific models of Extractor Pro RX Retrieval Balloon Catheter because the label incorrectly shows where the skive hole is positioned relative to the balloon. This error could cause improper use during medical procedures if the catheter is used without correcting the label.
The catheter label incorrectly states that the skive hole should be above the balloon, but it is actually positioned below. This labeling error could lead to improper use during medical procedures if the catheter is used without correcting the label.
Medical professionals who use these catheters for procedures are likely affected. The risk is low as the error is a labeling issue rather than a safety hazard.
Check for the model numbers M00547030 (9-12mm Below) or M00547000 (9-12mm Above) on the catheter packaging or label. These models were sold with specific lot numbers.
Verify the skive hole position on the catheter label to ensure it matches the intended placement (above or below the balloon).
The catheter label incorrectly states the skive hole should be above the balloon, but it is actually positioned below, which could lead to improper use during medical procedures.
The affected models are M00547030 (9-12mm Below) and M00547000 (9-12mm Above).
No, the recall is for labeling correction, not a safety hazard. You can continue using it as long as you verify the skive hole position.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2618-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2618-2025 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.
