Boston Scientific recalls Guider Softip Guide Catheters with incorrect tip curve shape that may affect medical procedures. Affected products have specific lot numbers and catalog numbers.
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 may impact medical procedures. This issue could lead to improper catheter function during cardiac procedures.
The catheters have a tip curve shape that differs from what's labeled, which could cause improper guidance during cardiac procedures. This might lead to incorrect placement or complications during medical treatments.
Cardiac catheterization patients and medical professionals using the recalled Guider Softip Guide Catheters. Those with the specific lot numbers listed in the recall are most at risk.
Check for the catalog number M003101460 and lot numbers listed in the recall (e.g., 26059697, 26339267, etc.). The product is a cardiac guide catheter sold for medical use.
Review the catalog number and lot numbers to confirm if your catheter is affected.
Stryker Neurovascular observed that certain lots have an incorrect tip curve shape compared to the labeled design.
Check the catalog number and lot numbers to see if it's affected; the recall does not include a specific remedy.
The incorrect tip curve shape could lead to improper catheter function during medical procedures, but the recall does not specify serious injury risks.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0020-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0020-2024 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.
