Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to potential polyurethane layer delamination causing guidewire advancement problems. Affected units have specific batch numbers and model identifiers.
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 because some batches may have polyurethane layers that delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac procedures if the catheter becomes stuck.
The polyurethane layer in some catheters can delaminate, causing material to detach from the inner lining. This may prevent guidewires from advancing properly through the catheter, potentially leading to complications during cardiac procedures.
Cardiologists and medical professionals who use these catheters for cardiac procedures are most at risk. Patients undergoing procedures with affected catheters may experience complications if the catheter becomes stuck.
Check for model number 5F EXPO CAS1 (5PK), reference number H749085261712, and batch numbers 60447174. The catheter has a unique identifier UDI/DI 08714729187776.
Identify the model number, reference number, and batch numbers to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination in certain batches, which can cause guidewires to become stuck during procedures.
Check the model number, reference number, and batch numbers to see if your catheter is affected. If it is, contact Boston Scientific for guidance.
Yes, if the catheter becomes stuck during a procedure, it could lead to complications for patients.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1645-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1645-2024 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.
