Boston Scientific recalls Expo 5F Selective Angiographic Catheters with potential guidewire advancement problems. The catheters may have polyurethane layer delamination causing material detachment in the inner lining.
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 issues with guidewire advancement. This happens due to polyurethane layer delamination that can cause material detachment in the catheter's inner lining.
The catheters may have a polyurethane layer that delaminates, causing material to detach from the inner lining. This can make it difficult to advance a guidewire through the catheter, potentially leading to complications during cardiac procedures.
Cardiologists and other medical professionals who use these catheters for cardiac procedures are affected. Patients undergoing procedures with these specific catheters may be at risk if the catheter malfunctions during the procedure.
Check for the model number 5F EXPO FL5 125CM (5PK) and batch number 60533582 on the catheter packaging or label. The catheter also has a unique identifier 08714729007579.
Look for the model number 5F EXPO FL5 125CM (5PK) and batch number 60533582 on the catheter packaging or label.
Boston Scientific recalls these catheters because some batches have polyurethane layer delamination that can cause material detachment in the inner lining, making it difficult to advance a guidewire.
Check for the model number 5F EXPO FL5 125CM (5PK) and batch number 60533582 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-1659-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1659-2024 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.
