Boston Scientific recalls Guider Softip Guide Catheter 5F 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 recall impacts specific model numbers and batch dates sold for cardiac use.
The catheter tip curve shape differs from what is labeled, which could lead to improper positioning during cardiac procedures. This might cause complications if the catheter does not function as intended.
Healthcare professionals using the Guider Softip Guide Catheter 5F for cardiac procedures are most at risk. Patients receiving these catheters during procedures may be affected.
Check for the catalog number M003100620 and batch numbers listed: 26277195, 26891778, 25715235, 25715236, 25761247, 25761248, 26059690, 26277194, 26599706, 27170548, 27444248, 27516585, 28057178, 28584686, 28595475, 28811944.
Identify the catalog number M003100620 and batch numbers listed in the recall notice.
Stryker Neurovascular observed that certain lots of Guider Softip XF Guide Catheters have an incorrect tip curve shape compared to the labeled shape.
The recall notice does not specify a remedy, so contact Boston Scientific directly for instructions.
Affected batch numbers include 26277195, 26891778, 25715235, 25715236, 25761247, 25761248, 26059690, 26277194, 26599706, 27170548, 27444248, 27516585, 28057178, 28584686, 28595475, 28811944.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0015-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0015-2024 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.
