Boston Scientific recalls Expo 5F Selective Angiographic Catheters with potential polyurethane layer delamination causing guidewire advancement issues. Affected units include specific batch numbers and model codes.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to reports of polyurethane layer delamination. This could prevent guidewires from advancing properly during cardiac procedures, potentially causing complications in medical treatments.
The polyurethane layer in some catheters may detach from the inner lining, creating issues with guidewire advancement. This could lead to complications during cardiac procedures if the catheter cannot be properly advanced through the blood vessels.
Cardiovascular patients undergoing cardiac catheter procedures who use the affected Expo 5F catheters. Medical professionals using the specific batch numbers listed are most at risk.
Check for the model number 5F EXPO AL2 (5PK) with batch numbers 60434245, 60454961, 60477302, 60510080, 60536207, 60447166, 60474029, 60483669, or 60533638, 60540481. The device has a unique identifier 08714729187943.
Verify the model number and batch numbers listed in the recall notice to confirm if your catheter is affected.
Boston Scientific reports increased complaints about polyurethane layer delamination in certain batches, which can cause guidewires to not advance properly during cardiac procedures.
Check the model number and batch numbers listed in the recall notice to determine if your catheter is affected. If it is, contact Boston Scientific for further instructions.
The recall indicates potential issues with guidewire advancement, which could lead to complications during procedures. However, the hazard is not described as causing immediate 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-1684-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1684-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
