Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to 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 because the polyurethane layer may delaminate, causing guidewire advancement problems. This could lead to complications during cardiac procedures if the catheter doesn't function properly.
The polyurethane layer in some batches may detach from the catheter's inner lining, making it difficult to advance a guidewire. This can cause procedural complications during cardiac catheterization if the catheter doesn't move as intended.
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 model number 5F EXPO FR5 (SGL), reference number H74908526031, and batch numbers 60466921. The catheter has a unique identifier (UDI/DI) 08714729366478.
Identify the model number, reference number, and batch numbers to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination causing guidewire advancement issues in some batches.
Batch numbers 60466921 are affected.
Check for model number 5F EXPO FR5 (SGL), reference number H74908526031, and batch number 60466921.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1640-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1640-2024 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.
