Boston Scientific recalls Expo 5F Selective Angiographic Catheters with potential polyurethane layer delamination causing guidewire advancement issues. Affected units have specific batch numbers and model identifiers.
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 catheters are used without proper function.
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.
Cardiovascular specialists and hospitals using the affected catheters. Patients undergoing cardiac catheterization procedures are at risk if they receive the recalled units.
Check for the model number 5F EXPO AR MOD (5PK) and batch numbers 60443056, 60452071, 60464497, 60467054, 60475380, 60511251, 60498235, or 60533590. The catheter has a unique identifier UDI/DI 08714729007692.
Identify the batch numbers and model identifiers on the catheter to determine if it is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination that may cause material detachment in the inner lining, potentially making it difficult to advance a guidewire.
Affected batch numbers are 60443056, 60452071, 60464497, 60467054, 60475380, 60511251, 60498235, and 60533590.
Check for the model number 5F EXPO AR MOD (5PK) and the specific batch numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1682-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1682-2024 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.
