FDA Medical Device Recalls (openFDA)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
- Recall number
- Z-0464-2022
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Product
- Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
- Status
- Terminated
- Initiated
- 2021-11-19
- Posted
- not on file
- Terminated
- 2024-08-16
- Reason
- There have been reports of stent migration.
- 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
- 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,
- Lot, serial or model codes
- The IFU for all model numbers and serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- ["P200026"]
- Product code
- QAN
- Firm FEI
- 2182208
- Firm city
- Mounds View
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28