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 could prevent guidewires from advancing properly, potentially causing medical complications during procedures.
The polyurethane layer in some batches can delaminate, causing material detachment in the catheter's inner lining. This may prevent guidewires from advancing through the device, which is critical during cardiac procedures.
Cardiologists and medical professionals using the recalled catheters for cardiac procedures. Patients undergoing these procedures with affected catheters may face complications.
Check for model number 5F EXPO IMC (5PK), batch numbers 60448987, 60467091, 60476275, 60486323, or 60535894. The catheter has a unique identifier 08714729249214.
Look for batch numbers 60448987, 60467091, 60476275, 60486323, or 60535894 on the catheter packaging.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination that may cause guidewires to not advance properly during procedures.
Check the batch numbers on the catheter packaging. If it matches the listed batch numbers, contact Boston Scientific for guidance.
The recall addresses potential complications during cardiac procedures, but the specific risk to patients depends on the procedure and medical context.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1651-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1651-2024 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.
