Boston Scientific recalls Expo 5F Selective Angiographic Catheters with 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 due to reports of polyurethane layer delamination that may prevent guidewire advancement. This could lead to complications during cardiac procedures if the catheter fails to move properly.
The catheters may develop a delamination in the polyurethane layer, causing material detachment in the inner lining. This can make it difficult or impossible to advance a guidewire through the device, potentially leading to procedural complications.
Cardiologists and medical professionals who use the recalled catheters for cardiac procedures are most at risk. Patients undergoing procedures with these specific catheters may face complications if the device malfunctions.
Check for the model number 5F EXPO KIMNY (5PK) and batch numbers 60504831, 60515598, or 60533629. The catheters were sold with UDI/DI 08714729249030.
Identify the model number and batch numbers to confirm if your catheter is affected.
Boston Scientific recalls these catheters due to reports of polyurethane layer delamination causing guidewire advancement issues in certain batches.
Check the model number and batch numbers to see if your catheter is affected. Contact Boston Scientific for further instructions.
The recall addresses potential complications during cardiac procedures if the catheter fails to advance properly, but the specific risk to patients is not detailed in the notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1646-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1646-2024 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.
