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 procedures if the catheter fails to move 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 a guidewire through the device, potentially leading to procedural complications during cardiac catheterization.
Cardiologists and medical professionals using the recalled catheters for cardiac procedures. Patients undergoing procedures with these specific catheters may be at risk if the catheter malfunctions.
Check for the model number 5F EXPO FR4 MOD (5PK) and batch numbers 60448979, 60500188, or 60535893. The catheter has a unique identifier (UDI/DI) 08714729248705.
Identify the model number and batch numbers listed in the recall notice to confirm if your catheter is affected.
The recalled catheters are model 5F EXPO FR4 MOD (5PK) with batch numbers 60448979, 60500188, and 60535893.
There are reports of polyurethane layer delamination in some batches, which can cause material detachment and make it difficult to advance a guidewire during cardiac procedures.
The recall does not require immediate discontinuation; however, affected units should be checked against the listed batch numbers and model to ensure safety.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1643-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1643-2024 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.
