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 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 due to reports of polyurethane layer delamination that may prevent guidewire advancement. This could lead to complications during cardiac procedures if the catheter fails to advance properly.
The polyurethane layer in some batches may delaminate, causing material detachment in the catheter's inner lining. This can make it difficult to advance the guidewire through the device, potentially leading to procedural complications.
Cardiovascular specialists and hospitals using the affected catheters. Patients undergoing cardiac catheterization procedures are at risk if they receive the recalled models.
Check for the model number 5F EXPO AR2 (5PK) and batch numbers listed: 60430930, 60447169, 60462004, 60475385, 60515237, 60525060, 60447168, 60461420, 60474038, 60486305, 60522598, 60531431, 60540176.
Verify the model number and batch numbers listed in the recall notice to confirm if your catheter is affected.
The polyurethane layer may delaminate, causing material detachment in the inner lining that can prevent guidewire advancement during procedures.
Batch numbers 60430930, 60447169, 60462004, 60475385, 60515237, 60525060, 60447168, 60461420, 60474038, 60486305, 60522598, 60531431, and 60540176.
The recall indicates a potential issue but does not require immediate discontinuation. Affected users should check the batch numbers and contact Boston Scientific if needed.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1681-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1681-2024 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.
