Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination causing guidewire advancement issues. 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 the polyurethane layer can delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac procedures if the catheter fails to function properly.
The polyurethane layer in some batches can delaminate, causing material detachment in the catheter's inner lining. This may prevent guidewires from advancing through the device, potentially leading to procedural complications.
Cardiologists and medical professionals using the recalled catheters for cardiac procedures. Patients undergoing procedures with these catheters may be at risk if the device malfunctions.
Check for the model number 5F EXPO JIG4 (5PK) and batch numbers 60500256 or 60536210. The catheter has a unique identifier UDI/DI 08714729886143.
Verify the model number, batch numbers, and unique identifier to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to evidence of polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during procedures.
Batch numbers 60500256 and 60536210 are affected.
Check for the model number 5F EXPO JIG4 (5PK) and batch numbers 60500256 or 60536210 on the catheter's label.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1664-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1664-2024 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.
