Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
NC Trek RX Coronary Dilatation Catheter Recalled by Abbott Vascular Due to Products from the identified lots may exhibit difficulty...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Vascular directly.
Affected Products
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451-20, 1012451-25, 1012452-08, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20
Quantity: 449,661 units total (132,040 units in US)
Why Was This Recalled?
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Where Was This Sold?
US and Worldwide
About Abbott Vascular
Abbott Vascular has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report