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 polyurethane layer delamination that can cause guidewire advancement problems. This may lead to complications during cardiac catheter procedures.
The polyurethane layer in some batches can delaminate, causing material detachment in the catheter's inner lining. This may prevent guidewires from advancing properly during procedures, potentially leading to complications.
Cardiovascular patients undergoing cardiac catheter procedures who use the affected catheters. Medical professionals performing these procedures are most at risk.
Check for the model number 5F EXPO IM (5PK) with batch numbers: 60432320, 60447145, 60468840, 60491659, 60515603, 60523996, 60438675, 60459197, 60475371, 60495554, 60522591, 60533644, 60440974, 60467093, 60483661, 60504885, 60522595, 60536197.
Identify the batch numbers listed in the recall notice to confirm if your catheter is affected.
The polyurethane layer in certain batches can delaminate, causing material detachment in the catheter's inner lining that may prevent guidewires from advancing properly during procedures.
Check the batch numbers listed in the recall notice to determine if your catheter is affected. If it is, contact Boston Scientific for further instructions.
While the hazard may cause guidewire advancement issues, the recall indicates a low-risk situation where complications are possible but not guaranteed.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1649-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1649-2024 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.
