Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Abre Venous Self-expanding Sent System Recalled by Medtronic Inc. Due to Incorrect size printed on the device; packaging is...
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 Medtronic Inc. directly.
Affected Products
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Quantity: 23 devices
Why Was This Recalled?
Incorrect size printed on the device; packaging is labeled correctly.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc.
Medtronic Inc. has 85 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report