FDA-Device2026-01-21Class IIPROCESSING DEFECT
Medtronic Abre Venous Self-Expanding Stent System recalled for stent migration risk
OTHERNationwide distribution
Contact your doctor about Medtronic Abre stent
Medtronic has recalled certain Abre Venous Self-Expanding Stents due to a manufacturing issue with the stent material (Nitinol) that can cause the stent to be smaller than intended when deployed. This reduced size may result in the stent moving out of position after placement.
- If you received an Abre stent, contact your doctor or cardiologist right away with your stent information
- Do not delay or stop any prescribed medications or treatments without medical guidance
- Provide your doctor with your stent lot or serial number if available (found in medical records)
- Your doctor will advise whether monitoring, imaging, or additional treatment is needed
Hazard
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Sold states
Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam.
Affected count
442
Manufactured in
4600 Nathan Ln N, Plymouth, MN, United States
Products
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1098-2026Don't want to check this manually?
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