Boston Scientific recalls Expo 5F Selective Angiographic Catheters with polyurethane layer delamination that may cause guidewire advancement issues. Affected units include specific batch numbers and model.
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 a polyurethane layer that may delaminate, causing guidewire advancement problems. This could lead to complications during cardiac procedures if the catheter fails to advance properly.
The polyurethane layer in some batches may delaminate, causing material detachment in the catheter's inner lining. This can prevent guidewires from advancing through the catheter, potentially leading to procedure complications.
Cardiovascular specialists and hospitals using the affected catheters. Patients undergoing cardiac procedures with these specific models are at risk if the catheter malfunctions during treatment.
Check for the model number 5F EXPO AL3 (5PK) with batch numbers 60448983, 60461410, 60476253, 60486049, or 60517315. The catheter has a unique identifier 08714729187721.
Identify the model number 5F EXPO AL3 (5PK) and batch numbers listed in the recall notice.
Reach out to Boston Scientific for further guidance on handling the affected catheters.
The polyurethane layer may delaminate in some batches, causing material detachment in the inner lining and preventing guidewire advancement during procedures.
Batch numbers 60448983, 60461410, 60476253, 60486049, and 60517315 are affected.
Check for the model number 5F EXPO AL3 (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-1644-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1644-2024 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.
