Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to potential wire advancement problems. Affected units have polyurethane layer delamination risks.
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 may have polyurethane layers that delaminate, causing guidewire advancement issues. This could lead to complications during cardiac procedures if the catheter doesn't move properly.
The polyurethane layer in some catheters can delaminate, causing material to detach from the inner lining. This may prevent guidewires from advancing through the catheter, potentially leading to procedural complications during cardiac catheterization.
Cardiologists and cardiac catheterization staff who use the recalled catheters are most at risk. Patients undergoing procedures with these specific catheters may face complications if the guidewire cannot advance.
Check for the model number 5F EXPO CLS2.5 (5PK) and batch number 60468842 on the catheter packaging or label. The product was sold with UDI/DI 08714729812166.
Look for the model number 5F EXPO CLS2.5 (5PK) and batch number 60468842 on the catheter packaging or label.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during cardiac procedures.
Check for the model number 5F EXPO CLS2.5 (5PK) and batch number 60468842 on the catheter packaging or label. The product was sold with UDI/DI 08714729812166.
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1676-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1676-2024 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.
