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 5F Selective Angiographic Catheters because some batches have a polyurethane layer that may delaminate, causing guidewire advancement problems. This could lead to complications during medical procedures if the catheter is used without proper function.
The polyurethane layer in some batches can delaminate, causing material detachment in the catheter's inner lining. This may prevent the guidewire from advancing through the device, potentially leading to procedural complications during cardiac catheterization.
Cardiologists and medical professionals who use these catheters for cardiac procedures are most at risk. Patients undergoing procedures with the recalled catheters may experience complications if the device fails to advance properly.
Check for the model number 5F EXPO FL4 (5PK) with batch numbers listed in the recall: 60427721, 60437784, 60456288, and other specific batch numbers provided in the recall notice. The catheter is used in cardiac procedures and has a unique identifier.
Identify the batch number on the catheter packaging or label to determine if it is affected by this recall.
Boston Scientific recalls certain batches of Expo 5F Selective Angiographic Catheters due to potential polyurethane layer delamination, which can cause guidewire advancement issues during medical procedures.
Check the batch number on the catheter packaging or label. Affected units include specific batch numbers listed in the recall notice, such as 60427721, 60437784, 60456288, and others provided in the recall.
No, the recall does not require immediate discontinuation. Medical professionals should check the batch number and follow the provided steps to ensure safe use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1655-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1655-2024 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.
