Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Instructions for Use for all model numbers of the Medtronic Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Due to There have been reports of stent migration.

Date: November 19, 2021
Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Status: Terminated
Source: FDA (Device)

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., Cardiac Rhythm and Heart Failure (CRHF) directly.

Affected Products

Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

Quantity: 21,653 devices

Why Was This Recalled?

There have been reports of stent migration.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 198 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report