Z-0464-2022Class II

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

Name: Z-0464-2022 Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2021-11-19
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-11-19 / Terminated

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System on 2021-11-19. FDA classified it as Class II and gives the reason as "There have been reports of stent migration". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0464-2022
Classification: Class II
Status: Terminated
Initiated: 2021-11-19
Posted: 2022-01-06
Terminated: 2024-08-16
Recalling firm: Medtronic, Inc.
Product: Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Product code: QAN Stent, Iliac Vein
Reason for recall: There have been reports of stent migration.
FDA root cause: Other
Action: The firm issued letters dated November 2021 on 11/19/2021 via 2-day UPS delivery to the U.S. consignees. The letter informs the consignee of the upcoming updates to the Instruction for Use (IFU) for the Abre venous self-expanding stent system and explains the updates will provide new information to help mitigate the risk of possible stent migration. The Customer Instructions in the letter requests the enclosed upcoming updates to the IFU be reviewed, the letter is shared with all those who need to be aware within their organization, patients should continue to be monitored per their practice's normal follow-up procedures, and the enclosed Customer Confirmation Form be completed and emailed to the firm. The updated electronic IFU will be available before the end of the calendar year. In Outside the United States (OUS) geographies, communication of the Medical Device Correction letter began 11/24/2021 via regionally approved methods. Consignees will be notified of the upcoming IFU change, as well as provided the content of the IFU change. Consignees will be asked to complete and return a confirmation certificate confirming they have received the notification. The IFU for OUS consignees will be available in the summer of 2022.
Quantity in commerce: 21,653 devices
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 Republic, Denmark, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kenya, Lithuania, Malaysia, Republic of Moldova, Netherlands, New Zealand, Nicaragua, Norway, Oman, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, and Viet Nam,
Product codes and lots: The IFU for all model numbers and serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0464-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0464-2022	Class II	Terminated	Voluntary: Firm initiated	2022-01-12	2022-01-06

Product code QAN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)