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 reports of polyurethane layer delamination. This can cause guidewires to become stuck, potentially leading to complications during cardiac procedures.
The polyurethane layer in some batches of these catheters can delaminate, causing material to detach from the inner lining. This may prevent guidewires from advancing properly through the catheter, potentially causing complications during cardiac procedures.
Cardiologists and medical professionals using the recalled catheters for cardiac procedures are most at risk. Patients undergoing these procedures with affected catheters may experience complications.
Check for batch numbers 60447151, 60456265, 60472610, 60486304, 60522592, or 60531432 on the catheter packaging. The product is labeled as 'Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK).'
Look for batch numbers 60447151, 60456265, 60472610, 60486304, 60522592, or 60531432 on the catheter packaging.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination in certain batches, which can cause guidewires to become stuck during procedures.
Check the batch numbers on the catheter packaging. If you have a batch number listed above, contact Boston Scientific for guidance.
The recall is for medical professionals using the catheters during procedures. Patients undergoing procedures with affected catheters may experience 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-1650-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1650-2024 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.
