Boston Scientific recalls Expo 5F Selective Angiographic Catheters with polyurethane layer delamination that may cause 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 due to reports of polyurethane layer delamination. This could prevent guidewires from advancing properly during procedures, potentially causing complications.
The polyurethane layer in some batches may delaminate, causing material detachment inside the catheter's inner lining. This can make it difficult or impossible to advance a guidewire through the device during procedures, potentially leading to complications.
Cardiovascular specialists and hospitals using the affected catheters. Patients undergoing cardiac procedures with these specific models are at risk of procedural complications.
Check for the model number 5F EXPO FR3.5 (5PK) and batch numbers listed: 60425778, 60427745, 60438674, 60456279, 60465785, 60476456, 60427256, 60430877, 60440972, 60465783, 60472599, 60479447, 60427594, 60430933, 60449235, 60465784, 60474047, 60479448, 60474048, 60522588.
Review the batch numbers listed in the recall notice to determine if your catheter is affected.
Reach out to Boston Scientific for guidance on next steps if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during procedures.
Check the batch numbers against the list provided in the recall notice. Contact Boston Scientific for further instructions if your catheter is affected.
The recall addresses potential complications during procedures due to guidewire advancement issues, but the risk is not immediate for patients outside of medical 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-1638-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1638-2024 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.
