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. This could prevent guidewires from advancing through the catheters, potentially causing complications during cardiac procedures.
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, which is critical during cardiac catheterization procedures.
Cardiovascular professionals using the recalled catheters for cardiac procedures are most at risk. Patients undergoing procedures with these specific catheters may experience complications.
Check for the model number 5F EXPO FL5 (5PK) and batch numbers listed: 60432312, 60448988, 60448989, 60459201, 60464505, 60465484, 60467102, 60467103, 60467104, 60467105, 60467106, 60467107, 60467121, 60469088, 60477210, 60477211, 60477213, 60479437, 60479438, 60481581, 60481582.
Identify the model number 5F EXPO FL5 (5PK) and batch numbers listed in the recall notice.
The polyurethane layer may delaminate, causing material detachment in the inner lining and making it difficult to advance guidewires through the device.
Batch numbers 60432312, 60448988, 60448989, 60459201, 60464505, 60465484, 60467102, 60467103, 60467104, 60467105, 60467106, 60467107, 60467121, 60469088, 60477210, 60477211, 60477213, 60479437, 60479438, 60481581, 60481582.
The recall does not specify a stop-use action; affected users should check product details and contact Boston Scientific 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-1685-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1685-2024 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.
