Boston Scientific recalls Expo 5F Selective Angiographic Catheters with polyurethane layer delamination that may cause guidewire advancement issues during cardiac procedures.
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. This could prevent guidewires from advancing properly during cardiac catheter procedures, potentially causing procedure complications.
The polyurethane layer in some batches may delaminate, causing material detachment in the catheter's inner lining. This can make it difficult to advance guidewires through the device during cardiac catheter procedures, potentially leading to procedure complications.
Cardiovascular specialists and hospitals using the recalled catheters. Patients undergoing cardiac procedures with these specific models are at risk of procedural complications.
Check for the model number 5F EXPO WRP (5PK) with batch numbers: 60442603, 60448206, 60463966, 60481407, 60491911, 60492607, 60443053, 60457140, 60467045, 60485945, 60492554, 60492608, 60443054, 60457142, 60467046, 60488392, 60492605, 60448186, 60463965, 60481406, 60488393, 60492606.
Verify the model number is 5F EXPO WRP (5PK) with the listed batch numbers.
Boston Scientific reports increased complaints about polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during cardiac procedures.
Check for the model number 5F EXPO WRP (5PK) with batch numbers: 60442603, 60448206, 60463966, 60481407, 60491911, 60492607, 60443053, 60457140, 60467045, 60485945, 60492554, 60492608, 60443054, 60457142, 60467046, 60488392, 60492605, 60448186, 60463965, 60481406, 60488393, 60492606.
The recall record does not specify a remedy, so contact Boston Scientific directly for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1675-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1675-2024 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.
