Boston Scientific recalls certain Expo 5F Selective Angiographic Catheters due to potential polyurethane layer delamination causing guidewire advancement issues. Affected units include specific batch numbers and model.
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 specific batches of Expo 5: Selective Angiographic Catheters because the polyurethane layer may delaminate, causing guidewire advancement problems. This could lead to complications during cardiac procedures if the catheter doesn't move properly.
The polyurethane layer in some batches may delaminate, causing material detachment in the catheter's inner lining. This can prevent the guidewire from advancing through the device, potentially leading to complications during cardiac procedures.
Cardiologists and medical professionals using the affected catheters for cardiac procedures. Patients undergoing these procedures with the recalled models are at risk if the catheter malfunctions.
Check for the model number 5F EXPO CLS3 (5PK) and batch numbers 60436618, 60477262, 60477325, 60535891, or 60540487. The catheter has a unique identifier UDI/DI 08714729812180.
Verify the model number and batch numbers listed in the recall notice to confirm if your catheter is affected.
Reach out to Boston Scientific directly for further guidance if you have the affected catheter.
The recalled model is Expo 5F Selective Angiographic Catheters with model number 5F EXPO CLS3 (5PK).
Batch numbers 60436618, 60477262, 60477325, 60535891, and 60540487 are affected.
The recall notice does not specify a fix; affected users should contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1677-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1677-2024 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.
