Boston Scientific recalls Guider Softip Guide Catheter 7F models with incorrect tip curve shape. Affected units may not function properly during cardiac procedures. Contact for remedy 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 due to an incorrect tip curve shape that could affect medical procedures. This issue may lead to improper catheter function during cardiac treatments.
The catheters have a tip curve shape that differs from what's labeled. This could cause improper positioning during cardiac procedures, potentially leading to complications.
Healthcare professionals using the specific catheter models are most at risk. Patients receiving these catheters during procedures may be affected.
Check for the catalog number M003101430 and lot numbers: 27241919, 27516638, 27780467, 27780470, 28065090, 26138318, 26891812, 28676781, 28595471, 28676782, 28886804, 28910751.
Verify the catalog number M003101430 and lot numbers listed in the recall notice.
Stryker Neurovascular observed that certain lots have an incorrect tip curve shape compared to the labeled design.
The recall notice does not specify a remedy, so contact Boston Scientific for further instructions.
Yes, affected lot numbers include 27241919, 27516638, 27780467, 27780470, 28065090, 26138318, 26891812, 28676781, 28595471, 28676782, 28886804, 28910751.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0018-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0018-2024 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.
