Boston Scientific recalls certain Guider Softip Guide Catheters due to incorrect tip curve shape, which may affect medical procedures. Affected products include 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 specific lots of Guider Softip Guide Catheters because they have an incorrect tip curve shape compared to what's labeled. This could lead to improper use during medical procedures, but the recall does not mention immediate safety risks.
The catheters have a tip curve shape that differs from the labeled design. This could potentially lead to improper guidance during medical procedures, but the recall does not specify a risk of injury or serious harm.
Healthcare professionals who use the Guider Softip Guide Catheters for cardiac procedures are most likely affected. Patients receiving these catheters during procedures may also be impacted if the incorrect tip curve causes issues.
Check for the catalog number M003100630 and lot numbers 25651754, 25651753, 25761245, 26059691, 26409982, 26599707, or 27219434. The product is a cardiac guide catheter sold under the Guider Softip brand.
Verify the catalog number and lot numbers listed in the recall notice 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 medical procedures.
The recall notice does not specify a remedy, so check the product details to see if it's affected and contact Boston Scientific for further instructions.
The recall does not mention a risk of injury or serious harm, so the hazard is considered low risk.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0016-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0016-2024 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.
