Boston Scientific recalls Guider Softip Guide Catheters 8F PRE-SHAPED 40 100CM with incorrect tip curve shape. Affected lots may not function properly 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 8F PRE-SHAPED 40 100CM due to an incorrect tip curve shape. This could lead to improper function during cardiac procedures, potentially causing complications.
The catheters have a tip curve shape that differs from what's labeled. This could cause improper function during cardiac procedures, but the hazard is not described as causing injury in normal use.
Cardiac catheterization patients and medical professionals using the specific recalled model. The risk is low as the issue relates to tip shape accuracy rather than immediate safety hazards.
Check for the catalog number M003101440 and lot numbers listed in the recall notice. The product is a cardiac guide catheter used in medical procedures.
Verify the catalog number M003101440 and lot numbers from the recall list to confirm if your catheter is affected.
The recall is due to certain lots having an incorrect tip curve shape compared to the labeled design, which could affect proper function during cardiac procedures.
Check for the catalog number M003101440 and lot numbers listed in the recall notice (25823581, 26059696, etc.).
The recall notice does not specify a remedy; you should check with Boston Scientific for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0019-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0019-2024 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.
