Boston Scientific recalls Expo 5F Selective Angiographic Catheters with polyurethane layer delamination that may cause guidewire advancement issues. Affected units have specific batch numbers and model identifiers.
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. This could prevent guidewires from advancing properly during cardiac procedures, potentially causing complications.
The polyurethane layer in some batches may detach from the catheter's inner lining. This delamination can cause the catheter to become difficult or impossible to advance with guidewires during procedures, increasing procedure complexity and potential complications.
Cardiovascular specialists and hospitals using the affected catheters. Patients undergoing cardiac procedures with these specific models are most at risk.
Check for the model number 5F EXPO LCB (5PK) and batch numbers: 60443926, 60463398, 60472605, 60473187, 60498234, 60524982, 60513387, 60533587, 60535875. The catheter has a unique identifier UDI/DI 08714729187790.
Identify the batch numbers and model identifiers listed in the recall notice to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination that may cause guidewires to become stuck during procedures.
Check for the model number 5F EXPO LCB (5PK) and batch numbers: 60443926, 60463398, 60472605, 60473187, 60498234, 60524982, 60513387, 60533587, 60535875.
The recall notice does not specify a remedy or action for affected units. Check with Boston Scientific for further 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-1648-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1648-2024 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.
