Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination causing guidewire blockage in some batches. Affected units have specific model and batch numbers.
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 polyurethane layers that can delaminate, potentially blocking guidewires during use. This could lead to complications in cardiac procedures if the catheter cannot advance properly.
The polyurethane layer in some catheters can delaminate, causing material to detach from the inner lining. This may block guidewires during procedures, preventing proper advancement of the catheter and potentially causing complications.
Cardiovascular specialists and hospitals using the recalled catheters are most at risk. Patients undergoing cardiac catheterization with affected units may face complications.
Check for model number 5F EXPO CLS4 (5PK) and batch number 60442614. The catheter has a unique identifier 08714729812227.
Identify the model number 5F EXPO CLS4 (5PK) and batch number 60442614 on the catheter packaging or label.
Boston Scientific recalls these catheters due to evidence of polyurethane layer delamination in some batches, which can cause guidewire blockage during procedures.
Check for model number 5F EXPO CLS4 (5PK) and batch number 60442614 on the catheter packaging or label.
The recall record does not specify a remedy, so contact Boston Scientific directly 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-1679-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1679-2024 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.
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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.
