Boston Scientific recalls Expo 5F Selective Angiographic Catheters (model 5F EXPO FL3) due to polyurethane layer delamination causing guidewire advancement issues. Affected units have specific batch numbers and UDI/DI codes.
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 some batches have polyurethane layers that delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac procedures if the catheter becomes stuck or detached.
The polyurethane layer in some catheters can delaminate, causing material to detach from the inner lining. This may prevent guidewires from advancing properly through the catheter, potentially leading to complications during cardiac procedures if the catheter gets stuck or detaches.
Cardiovascular specialists and medical facilities using the recalled catheters. Patients undergoing cardiac procedures with these specific models are at risk if the catheter becomes stuck or detached during treatment.
Check for the model number 5F EXPO FL3 (5PK) with batch numbers: 60433909, 60459200, 60467047, 60486322, 60504866, 60533642, 60447140, 60463976, 60474043, 60504859, 60517330. Also look for the UDI/DI code 08714729376675.
Verify the model number, batch numbers, and UDI/DI code to confirm if your catheter is affected.
Boston Scientific recalls these catheters because some batches have polyurethane layers that delaminate, causing guidewire advancement issues during cardiac procedures.
Check the model number, batch numbers, and UDI/DI code to see if your catheter is affected. If it is, contact Boston Scientific for further instructions.
Yes, the delamination could cause the catheter to become stuck or detach during procedures, potentially leading to complications.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1652-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1652-2024 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.
