Boston Scientific recalls certain Guider Softip Guide Catheters with incorrect tip curve shapes. 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 Guider Softip Guide Catheters that have 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 is labeled. This could cause improper guidance during cardiac procedures, potentially leading to complications.
Cardiologists and medical professionals who use these catheters for cardiac procedures are most at risk. Patients undergoing procedures with the recalled catheters may experience complications.
Check for the catalog number M003101420 and lot numbers listed in the recall notice. The catheters are used in cardiac procedures and are sold under the Boston Scientific brand.
Verify the catalog number and lot numbers to confirm if your catheter is affected.
The recalled catheters have an incorrect tip curve shape compared to what is labeled, which could lead to improper function during cardiac procedures.
Check for the catalog number M003101420 and lot numbers listed in the recall notice: 26138711, 26276489, 26276490, 26590803, 26746110, 26891804, 26891805, 27162093, 27162094, 27203536, 27431372, 26059693, 26138710, 26276491, 26590802, 26746111, 27203537, 27219436, 27431373, 27526941, 27801040, 28811942, 28811943.
The recall notice does not specify a remedy, so you should check the product details to confirm if your catheter is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0017-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0017-2024 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.
