Boston Scientific recalls Guider Softip Guide Catheters with incorrect tip curve shape. Affected lots may not function as intended during cardiac procedures.
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Boston Scientific is recalling certain Guider Softip Guide Catheters due to an incorrect tip curve shape that could affect medical procedures. This recall affects specific lots that may not function properly during cardiac catheterization.
The catheters have a tip curve shape that differs from what's labeled, which might cause improper positioning during cardiac procedures. This could lead to complications like vessel damage or inaccurate procedure outcomes.
Cardiologists and medical professionals who use the recalled catheters for cardiac procedures are most at risk. Patients undergoing these procedures with the affected catheters could experience complications.
Check for the catalog number M003101630 and lot numbers 25715222, 27762225, or 27780464 on the catheter packaging or label.
Verify the catalog number and lot numbers on the catheter packaging to confirm if it's affected.
Certain lots have an incorrect tip curve shape that may not function as intended during cardiac procedures.
Lot numbers 25715222, 27762225, and 27780464.
Look for the catalog number M003101630 and the specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0024-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0024-2024 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.
