Boston Scientific recalls Expo 5F Selective Angiographic Catheters (model 5F EXPO FR6) after reports of guidewire not advancing properly due to internal material detachment.
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 have internal material detachment that can prevent guidewire advancement. This could lead to complications during cardiac procedures if the catheter cannot be properly advanced.
The catheters have a polyurethane layer that can delaminate and detach from the inner lining in some batches. This causes the guidewire to become stuck, making it difficult to advance the catheter during procedures.
Cardiologists and cardiac catheterization staff who use the recalled catheters are most at risk. Patients undergoing procedures with these specific catheters may experience complications if the guidewire cannot advance.
Check for the model number 5F EXPO FR6 (5PK) and batch numbers 60493978 or 60530035 on the catheter packaging. The catheter also has a unique identifier 08714729187714.
Verify the model number, batch numbers, and unique identifier on the catheter packaging to confirm if it is recalled.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination and material detachment in the inner lining, which can prevent guidewire advancement during procedures.
Check the model number, batch numbers, and unique identifier on the packaging to see if it is recalled. If it is, contact Boston Scientific for further instructions.
The recall is for potential complications during procedures if the catheter cannot be advanced, but the risk is not described as causing serious injury in normal use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1642-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1642-2024 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.
