Boston Scientific recalls certain Guider Softip XF Guide Catheters with incorrect tip curve shape. These catheters 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 specific lots of Guider Softip Guide Catheters due to an incorrect tip curve shape. This could affect how the catheter functions during cardiac procedures, potentially leading to improper placement or complications.
The catheters have a tip curve shape that differs from what is labeled. This could cause improper placement during procedures, potentially leading to complications like vessel damage or incorrect treatment delivery.
Cardiovascular professionals who use these catheters for procedures are most at risk. Patients undergoing cardiac procedures with the recalled catheters may experience complications.
Check for the catalog number M003101480 and lot numbers listed in the recall notice. The product is a cardiac guide catheter used in medical procedures.
Review the catalog number and lot numbers to confirm if your catheter is affected.
Certain lots have an incorrect tip curve shape compared to the labeled design.
Check for catalog number M003101480 and lot numbers listed in the recall notice.
No action is needed if your catheter is not among the recalled lots.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0022-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0022-2024 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.
