Boston Scientific recalls Expo 5F Selective Angiographic Catheters (model 5F EXPO FL4 125CM) due to potential polyurethane layer delamination causing guidewire advancement issues. Affected units include specific batch numbers and reference 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 because some batches have polyurethane layers that may delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac procedures if the catheter becomes obstructed or detached.
The polyurethane layer in some batches may delaminate, causing material to detach from the catheter's inner lining. This can make it difficult to advance guidewires through the device, potentially leading to blockages or complications during cardiac procedures.
Cardiologists and cardiac catheterization staff who use the affected catheters during procedures are most at risk. Patients undergoing cardiac catheterization with these specific models may experience complications if the catheter malfunctions.
Check for the model number 5F EXPO FL4 125CM (5-pack) with reference code H749085262202. Affected units include batch numbers 60438212, 60449780, 60491491, 60491959, and 60521828.
Verify the model number, batch numbers, and reference codes listed in the recall notice to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during procedures.
Affected batches include 60438212, 60449780, 60491491, 60491959, and 60521828.
Check for the model 5F EXPO FL4 125CM (5-pack) with reference code H749085262202 and 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-1654-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1654-2024 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.
