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 certain Expo 5: Selective Angiographic Catheters because some batches have a polyurethane layer that may delaminate, causing problems with advancing guidewires. This could lead to complications during cardiac procedures if the catheter becomes stuck.
The polyurethane layer in some catheters may delaminate, causing material to detach from the inner lining. This can make it difficult to advance guidewires through the device, potentially leading to complications during cardiac procedures.
Cardiologists and cardiac catheterization teams using the recalled catheters. Patients undergoing procedures with these specific models are at risk if the catheter becomes stuck.
Check for the model number 5F EXPO CLS3.5 (5PK) and batch numbers 60447147, 60467099, or 60492626. The catheter has a unique identifier (UDI/DI) 08714729812203.
Identify the model number and batch numbers to confirm if your catheter is affected.
Boston Scientific recalls certain Expo 5F Selective Angiographic Catheters due to potential polyurethane layer delamination causing guidewire advancement issues.
Batch numbers 60447147, 60467099, and 60492626 are affected.
Check for the model number 5F EXPO CLS3.5 (5PK) and batch numbers 60447147, 60467099, or 60492626.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1678-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1678-2024 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.
