Boston Scientific recalls Guider Softip Guide Catheter 7F models 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 certain Guider Softip Guide Catheters 7F models due to an incorrect tip curve shape. This could affect how the catheter functions during cardiac procedures, potentially leading to improper placement or complications.
The catheters have a tip curve shape that differs from what's labeled. This could cause improper placement during cardiac procedures, potentially leading to complications if the catheter doesn't function as intended.
Healthcare professionals using these catheters for cardiac procedures are most at risk. Patients receiving these catheters during procedures may be affected if the tip curve shape is incorrect.
Check for the catalog number H965100430 and lot numbers listed in the recall notice. The catheters are used in cardiac procedures and have specific dimensions (40-90cm).
Identify the catalog number H965100430 and lot numbers from the recall list to confirm if your catheter is affected.
Stryker Neurovascular observed that certain lots of these catheters have an incorrect tip curve shape compared to the labeled shape.
Check for the catalog number H965100430 and lot numbers listed in the recall notice (26034355, 26034358, etc.).
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0010-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0010-2024 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.
