Boston Scientific recalls Expo 5F Selective Angiographic Catheters with potential polyurethane layer delamination. Affected units have specific batch numbers and model details. Consumers should contact for remedy.
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 due to reports of polyurethane layer delamination that could cause guidewire advancement issues. This may lead to complications during cardiac procedures if the catheter fails to function properly.
The polyurethane layer in some batches can delaminate, causing material detachment in the catheter's inner lining. This may prevent guidewires from advancing through the device, potentially complicating cardiac procedures.
Cardiologists and medical professionals who use the recalled catheters for cardiac procedures. Patients undergoing procedures with these specific catheters may be at risk if the device malfunctions.
Check for model number 5F EXPO IM 125CM (5PK) with batch numbers 60444872, 60451459, 60451968, or 60511220. The catheter has a unique identifier UDI/DI 08714729007593.
Identify 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 in certain batches, which can cause guidewire advancement issues during procedures.
Contact Boston Scientific directly to confirm if your catheter is affected and follow their instructions for remedy.
The recall addresses potential complications during procedures if the catheter malfunctions, but the risk is low for most users.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1660-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1660-2024 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.
