Boston Scientific recalls certain Guider Softip Guide Catheters 8F with incorrect tip curve shape. Affected products may have different tip curve than labeled, potentially causing improper catheter placement 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 8F due to an incorrect tip curve shape. This could lead to improper catheter placement during cardiac procedures, which might cause complications for patients.
The catheters have a tip curve shape that differs from what's labeled. This could cause the catheter to not position correctly during cardiac procedures, potentially leading to complications like improper vessel access or damage to blood vessels.
Healthcare professionals using the catheters for cardiac procedures are most at risk. Patients undergoing cardiac procedures with these specific catheters could experience improper placement.
Check for the catalog number H965100440 and lot numbers listed in the recall notice. The catheters are used in cardiac procedures and have a specific length (40-90cm).
Verify the catalog number H965100440 and lot numbers listed in the recall notice to confirm if your catheter is affected.
Stryker Neurovascular observed that certain lots of Guider Softip XF Guide Catheters have an incorrect tip curve shape compared to the labeled shape.
Check the catalog number and lot numbers to see if your catheter is affected. If it is, contact Boston Scientific for further instructions.
The recall indicates a potential for improper catheter placement during cardiac procedures, which could lead to complications. However, the specific risk level is not described as causing serious injury in normal use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0011-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0011-2024 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.
