Boston Scientific recalls certain Guider Softip Guide Catheters 6F 90CM 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 6F 90CM due to an incorrect tip curve shape that may affect their performance in cardiac procedures. This could lead to improper guidance during medical procedures if used without correction.
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 if the catheter does not function as intended.
Healthcare professionals using the recalled catheters for cardiac procedures are most at risk. Patients undergoing procedures with these catheters may experience complications if the tip curve shape is incorrect.
Check for the catalog number H965100460 and lot numbers listed in the recall notice. The affected products were distributed with a tip curve shape that differs from the labeled shape.
Identify the catalog number H965100460 and lot numbers from the list provided in the recall notice.
Certain lots have an incorrect tip curve shape that may differ from the labeled shape, potentially affecting performance during cardiac procedures.
Lot numbers 26059397, 26338716, 25822912, 25822914, 25822915, 25822916, 26059642, 26584704, 26585219, 26745658, 26745659, 26891768, 27177893, 27412261, 27504202, 27568860, 27754498, 27816607, 28100259, 28384661, 28502671, 28737894, 28737895, 26745657, 27177892, 28320873, 28584618, 28795038.
The recall does not require immediate stop use; healthcare professionals should check the lot numbers and follow the provided steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0012-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0012-2024 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.
