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 5F Selective Angiographic Catheters because some units may have a polyurethane layer that delaminates, making it difficult to advance guidewires. This could lead to complications during cardiac procedures if the catheter becomes stuck or detached.
The polyurethane layer in some catheters can delaminate, causing material to detach from the inner lining. This may make it difficult to advance guidewires through the catheter, potentially leading to complications during cardiac procedures if the catheter becomes stuck or detaches.
Cardiovascular specialists and hospitals using the recalled catheters are most at risk. Patients undergoing cardiac procedures with these specific batches may face complications if the catheter becomes stuck or detaches.
Check for the model number 5F EXPO FR5 125CM (5PK) with batch numbers 60449785, 60491507, or 60537491. The catheters were sold with UDI/DI 08714729007562.
Verify the model number, batch numbers, and UDI/DI code to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination causing guidewire advancement issues in some batches.
Check the model number, batch numbers, and UDI/DI code to determine if your catheter is affected. Contact Boston Scientific for further instructions.
Yes, the delamination could cause the catheter to become stuck or detach during use, potentially leading to complications in cardiac procedures.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1657-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1657-2024 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.
