Boston Scientific recalls Guider Softip Guide Catheters 7F 100CM with incorrect tip curve shape. Affected lots may not function properly during cardiac procedures. Consumers should contact Boston Scientific for details.
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 7F 100CM due to an incorrect tip curve shape. This could affect proper function during cardiac procedures. Affected products have specific lot numbers and may need to be returned or replaced.
The catheters have a tip curve shape that differs from what is labeled. This could lead to improper function during cardiac procedures, potentially causing complications.
Cardiovascular professionals who use the Guider Softip Guide Catheter 7F 100CM for cardiac procedures are most at risk. Patients receiving these catheters during procedures may also be affected.
Check the product label for the catalog number M003101470 and lot numbers: 26746117, 26891819, 27121009, 27435625, 26411755, 26746118, 27435626, 27444224, 27558596.
Look for the catalog number M003101470 and specific lot numbers listed in the recall notice.
The catheters have an incorrect tip curve shape compared to what is labeled, which could affect proper function during cardiac procedures.
Check the product label for catalog number M003101470 and lot numbers: 26746117, 26891819, 27121009, 27435625, 26411755, 26746118, 27435626, 27444224, 27558596.
The recall notice does not specify a remedy, so contact Boston Scientific directly for 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-0021-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0021-2024 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.
