Boston Scientific recalls Expo 5F Selective Angiographic Catheters with 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 due to reports of polyurethane layer delamination that may prevent guidewire advancement. This could lead to complications during cardiac catheter procedures.
The catheters may have a polyurethane layer that separates from the inner lining, causing material detachment. This can make it difficult to advance a guidewire through the device, potentially leading to procedural complications.
Cardiovascular specialists and hospitals using the affected catheters. Patients undergoing cardiac catheter procedures with these specific models are at risk.
Check for model number 5F EXPO FL4.5 (5PK), batch numbers 60443928, 60457123, 60464496, 60473188, 60504888, 60522597, 60477305, 60517337, or 60533589.
Verify the model number and batch numbers 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 guidewire advancement issues during procedures.
Batch numbers 60443928, 60457123, 60464496, 60473188, 60504888, 60522597, 60477305, 60517337, and 60533589 are affected.
The recall does not require immediate discontinuation; affected units should be checked against the listed batch numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1658-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1658-2024 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.
