Boston Scientific recalls Expo 5F Selective Angiographic Catheters with potential wire advancement problems due to polyurethane layer delamination. 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 issues where guidewires may not advance properly. This could happen due to material detachment in the catheter's inner lining, which might affect medical procedures.
The catheters' polyurethane layer may delaminate, causing material to detach from the inner lining. This can make it difficult to advance guidewires through the device, potentially leading to procedural complications.
Cardiologists and medical professionals using the recalled catheters for procedures. Patients undergoing cardiac catheterization with these specific models are at risk if the catheter malfunctions during treatment.
Check for the model number 5F EXPO TIG4 (5PK) and batch numbers 60447162, 60461412, 60474054, 60486303, 60495529, 60511248, 60511234, or 60531435. The catheters are used in cardiac procedures and have specific UDI/DI numbers.
Identify the model number 5F EXPO TIG4 (5PK) and batch numbers listed in the recall notice.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination causing guidewire advancement issues in some batches.
Check the model and batch numbers against the list provided in the recall notice to determine if your catheter is affected.
The recall addresses potential procedural complications during cardiac catheterization, but the risk is low as the issue affects specific batches and not all units.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1661-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1661-2024 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.
