Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to potential polyurethane layer delamination causing 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 because some batches have polyurethane layers that may delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac procedures if the catheter fails to function properly.
The polyurethane layer in some catheters may delaminate, causing material detachment in the inner lining. This can make it difficult to advance guidewires through the catheter, potentially leading to procedural complications during cardiac procedures.
Cardiovascular specialists and hospitals using the affected catheters. Patients undergoing cardiac procedures with these specific models are at risk if the catheter malfunctions during the procedure.
Check for the model number 5F EXPO FR5 (5PK) and batch numbers listed: 60429295, 60452070, 60467044, 60475390, 60491910, 60525061, 60430929, 60459221, 60472581, 60483688, 60498233, 60530044, 60512378, 60536198.
Identify the model number 5F EXPO FR5 (5PK) and batch numbers listed in the recall notice.
Boston Scientific recalls these catheters due to potential polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during cardiac procedures.
Affected batch numbers include 60429295, 60452070, 60467044, 60475390, 60491910, 60525061, 60430929, 60459221, 60472581, 60483688, 60498233, 60530044, 60512378, 60536198.
The recall notice does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1641-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1641-2024 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.
