“Medtronic Abre Venous Stent Recall: Stent Migration Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61519-medtronic-abre-venous-stent-recall-stent-migration-risk. Based on FDA recall #Z-0464-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0464-2022%22&limit=1).
The FDA announced on November 19, 2021, that Medtronic Inc. recalled Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System due to reports of stent migration. The recall was voluntary and classified as Class II.
The hazard
There have been reports of stent migration associated with the recalled device, according to the FDA.
Context
GovInfoNow's records show Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has had 29 other recalls on record since December 19, 2017. Other recent recalls of similar products include Medtronic Abre Venous Stent Recall: Nitinol Anomaly May Cause Stent Migration (December 4, 2025), INSPIREMD CGuard Prime Carotid Stent System Recall: Deployment Complications Risk (May 1, 2026), and CGuard Prime Carotid Stent System Recall: Deployment Complications Risk (May 1, 2026).
How to tell if you have this one
Check if your device is labeled as the Medtronic Abre Venous Self-Expanding Stent System. All model numbers and serial numbers are included in the recall.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Label
Look for the product name and model numbers on the device or its packaging.
Contact Medtronic
Reach out to Medtronic directly to confirm if your device is affected and get guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Czech…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0464-2022 (November 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0464-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.