Boston Scientific recalls Expo 5F Selective Angiographic Catheters (model 5F EXPO MULTIPACK SGL) after reports of guidewire not advancing properly due to internal layer delamination.
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 internal layer delamination that can prevent guidewire advancement. This could lead to complications during cardiac catheter procedures.
The polyurethane layer in some catheters can delaminate, causing material to detach from the inner lining. This may prevent guidewires from advancing through the catheter, potentially complicating cardiac procedures.
Cardiovascular specialists and hospitals using the recalled catheters (model 5F EXPO MULTIPACK SGL, batch numbers 60443927 and 60495422) are most at risk during procedures.
Check for the model 5F EXPO MULTIPACK (SGL) with batch numbers 60443927 or 60495422. The catheters have a unique identifier 08714729521501.
Identify the batch numbers and model to confirm if your catheter is recalled.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination causing guidewire advancement issues.
The official recall notice does not specify a remedy or action for affected users.
Yes, batch numbers 60443927 and 60495422 are affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1665-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1665-2024 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.
