Boston Scientific recalls Guider Softip Guide Catheters 7F 90CM with incorrect tip curve shape. Affected lots 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 90CM due to an incorrect tip curve shape that may affect their function during cardiac procedures. This could lead to improper guidance of medical devices in procedures.
The catheters have a tip curve shape that differs from what's labeled. This could cause the catheter to not guide properly during medical procedures, potentially leading to complications in cardiac interventions.
Cardiovascular professionals who use the recalled catheters for medical procedures are most at risk. Patients undergoing procedures with these catheters could be affected if the tip curve shape is incorrect.
Check for the catalog number H965100470 and lot numbers listed in the recall notice. The affected catheters are used in cardiac procedures and have specific model details.
Verify the catalog number H965100470 and lot numbers from the list provided 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.
Check the catalog number and lot numbers listed in the recall notice to determine if your catheter is affected.
The recall notice does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0013-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0013-2024 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.
