Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to potential polyurethane layer delamination causing guidewire advancement issues. Affected units have specific batch numbers and model identifiers.
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 may have polyurethane layers that delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac procedures if the catheter becomes obstructed or detached.
The polyurethane layer in some catheters may delaminate, causing material to detach from the inner lining. This can make it difficult to advance guidewires through the catheter, potentially leading to procedural complications if the catheter becomes obstructed or detached during cardiac procedures.
Cardiologists and medical professionals who use the recalled catheters for cardiac procedures. Patients undergoing procedures with these specific catheters are at risk if the catheter malfunctions during treatment.
Check for the model number 5F EXPO JIG3.5 (5PK) and batch number 60535890 on the catheter packaging or label. The product has a specific UDI/DI code 08714729886129.
Verify the model number 5F EXPO JIG3.5 (5PK) and batch number 60535890 on the catheter packaging or label.
Boston Scientific recalls these catheters due to potential polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during cardiac procedures.
Check the model number and batch number on the catheter packaging or label. If it matches the recalled specifications, contact Boston Scientific for further instructions.
The recall is for potential guidewire advancement issues, but Boston Scientific does not indicate a risk of serious injury in normal use. The hazard is described as a potential complication during procedures.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1663-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1663-2024 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.
