[Recalled] Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter — An increase in complaints related to an inability to advance the guidewire thro… | FDA 2024-03-21

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Boston Scientific Corporation

• VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract. — Class II
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• Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter — Class I
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.