Boston Scientific recalls Expo 5F Selective Angiographic Catheters (model 5F EXPO FR4 125CM) due to polyurethane layer delamination causing guidewire advancement issues. Affected units have specific batch numbers and UDI/DI codes.
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 polyurethane layers that may delaminate, 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 batches may delaminate, causing material detachment in the catheter's inner lining. This can make it difficult to advance guidewires through the device, potentially leading to complications during cardiac procedures.
Cardiologists and medical professionals using the recalled catheters for cardiac procedures. Patients undergoing procedures with these specific models are at risk if the catheter malfunctions.
Check for the model number 5F EXPO FR4 125CM (5-pack) with batch numbers 60430691, 60447156, 60463406, 60488300, 60493468, or 60537513. The UDI/DI code 08714729192817 also identifies affected units.
Verify the model number, batch numbers, and UDI/DI code to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to evidence of polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during cardiac procedures.
Check the product details for batch numbers and UDI/DI code to confirm if your catheter is affected. If it is, contact Boston Scientific for guidance.
Yes, the delamination could cause material detachment, making it difficult to advance guidewires and potentially leading to complications during 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-1656-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1656-2024 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.
