Boston Scientific recalls Expo 5F Selective Angiographic Catheters with polyurethane layer delamination risks. Affected units include specific batch numbers and model 5F EXPO FL3.5 (5PK).
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 cause guidewire advancement issues. This could lead to complications during cardiac procedures if the catheter fails to properly advance.
The catheters have a polyurethane layer that can delaminate and detach from the inner lining in some batches. This may cause the guidewire to become stuck during procedures, potentially leading to complications if the catheter cannot be advanced properly.
Cardiovascular professionals who use the recalled catheters for cardiac procedures are most at risk. Patients undergoing procedures with these specific catheters may experience complications if the catheter fails to advance properly.
Check for the model number 5F EXPO FL3.5 (5PK) and batch numbers listed in the recall notice. The product has a unique identifier (UDI/DI) of 08714729187813.
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.
The affected batch numbers are listed in the recall notice: 60423725, 60438648, 60449984, and other specific numbers.
The recall does not require immediate cessation of use; however, 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-1653-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1653-2024 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.
