Boston Scientific recalls certain Expo 5F Selective Angiographic Catheters due to 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 specific batches of Expo 5F Selective Angiographic Catheters because the polyurethane layer can delaminate, making it difficult to advance guidewires. This could lead to complications during cardiac catheter procedures if the catheter fails to function properly.
The polyurethane layer inside the catheter can delaminate and detach in some batches, causing the catheter to become difficult to advance with guidewires. This may lead to procedural complications during cardiac catheter procedures if the catheter fails to function as intended.
Cardiologists and medical professionals who use these catheters for cardiac procedures are most at risk. Patients undergoing procedures with the recalled catheters could face complications if the device malfunctions.
Check for the model number 5F EXPO MULTIPACK 145 (5PKX3) with batch numbers listed in the recall notice. The catheter has a unique identifier (UDI/DI) of 08714729187875.
Identify the batch numbers and model identifiers on the catheter to confirm if it is affected.
Reach out to Boston Scientific for further guidance on the recall and potential remedies.
Boston Scientific recalls these catheters due to evidence of polyurethane layer delamination in certain batches, which can cause guidewire advancement issues during procedures.
Affected batch numbers include 60422723, 60442593, 60463980, and other specific numbers listed in the recall notice.
No, but medical professionals should check the batch numbers and contact Boston Scientific for guidance before proceeding with 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-1668-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1668-2024 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.
