Boston Scientific recalls Expo 5F Selective Angiographic Catheters with potential polyurethane layer delamination that could cause guidewire advancement issues during cardiac procedures.
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 Angi: 5F EXPO MULTIPACK 145 (5PKX3) catheters due to reports of polyurethane layer delamination that may prevent guidewire advancement. This could lead to complications during cardiac catheter procedures.
The polyurethane layer in some batches may delaminate, causing material detachment in the catheter's inner lining. This can make it difficult to advance guidewires through the device during cardiac procedures, potentially leading to procedural complications.
Cardiovascular specialists and hospitals using the recalled catheters are most at risk. Patients undergoing cardiac catheter procedures with these specific models may experience complications.
Check for the model number 5F EXPO MULTIPACK 145 (5PKX3) with batch numbers 60447165, 60490140, or 60490183. The catheters are used in cardiac procedures and have a specific UDI/DI number 08714729249429.
Identify if your catheter has the model number 5F EXPO MULTIPACK 145 (5PKX3) with batch numbers 60447165, 60490140, or 60490183.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination that may cause guidewire advancement issues during cardiac procedures.
Check if your catheter matches the model and batch numbers listed in the recall notice. If it does, contact Boston Scientific for further instructions.
The recall addresses potential complications during cardiac procedures due to the catheter's inner lining issues, but no specific injury reports are mentioned.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1673-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1673-2024 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.
