Boston Scientific recalls Expo 5F Selective Angiographic Catheters with specific batch numbers due to potential guidewire advancement problems caused by polyurethane layer delamination.
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 batches of Expo 5F Selective Angiographic Catheters because some units may have polyurethane layers that delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac catheter procedures.
The polyurethane layer in some catheters can delaminate, causing material to detach from the inner lining. This makes it harder to advance guidewires through the catheter, potentially leading to procedural complications.
Cardiovascular professionals who use these catheters during procedures are most at risk. Patients undergoing cardiac catheterization with the recalled models may experience complications.
Check for batch numbers: 60427727, 60456253, 60462030, 60476271, 60500758, 60530055, 60436627, 60460188, 60474027, 60477271, 60502673, 60537578, 60438198, 60461419, 60475349, 60486289, 60515228. The product is a cardiac catheter with model number 5F EXPO MULTIPACK (5PKX3).
Look for batch numbers: 60427727, 60456253, 60462030, 60476271, 60500758, 60530055, 60436627, 60460188, 60474027, 60477271, 60502673, 60537578, 60438198, 60461419, 60475349, 60486289, 60515228.
Boston Scientific recalls these catheters because some units have polyurethane layers that delaminate, causing material detachment in the inner lining and making it difficult to advance guidewires.
Check the batch numbers listed in the recall notice. If you have a batch number from the list, contact Boston Scientific for guidance.
The recall notice does not specify a fix or remedy 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-1666-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1666-2024 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.
