Boston Scientific recalls certain Expo 5F Selective Angiographic Catheters (model 5F EXPO FR4) after reports of polyurethane layer delamination causing guidewire advancement problems.
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 specific batches of Expo 5F Selective Angiographic Catheters due to reports that the polyurethane layer may delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac procedures.
The catheters' polyurethane layer may delaminate, causing material detachment in the inner lining. This can make it difficult to advance guidewires through the device during procedures, potentially leading to complications.
Cardiovascular patients undergoing cardiac catheter procedures who use the recalled catheters. Patients using the specific batch numbers listed in the recall are most at risk.
Check for the model number 5F EXPO FR4 (5PK) with batch numbers listed in the recall (e.g., 60423767, 60436637, etc.). The catheters have a UDI/DI code of 08714729187691.
Review the model number and batch numbers listed in the recall to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination causing guidewire advancement issues during procedures.
Check for the model number 5F EXPO FR4 (5PK) with batch numbers listed in the recall (e.g., 60423767, 60436637, etc.).
The recall does not specify a remedy, so contact Boston Scientific directly for 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-1639-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1639-2024 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.
