Abre recallZ-1098-2026 · Medtronic Inc · initiated Dec 4, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Beginning 04-Dec-2025, Medtronic distributed an Urgent Medical Device Recall notice to all U.S. consignees who have impacted products via mail courier. Consignees were instructed to complete and return a response form to the firm and to return any affected product they may have.
Recall details
- Recall number
- Z-1098-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 4, 2025
- Posted by the FDA
- Jan 15, 2026
- Recalling firm
- Medtronic Inc
- Quantity
- 442
- Product code
- QAN
- FDA submissions
- P200026
- Distribution
- 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.
Product description
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 00763000547332 00763000547271 00763000547318 00763000547264 00643169796225 00643169796300 00643169796294 00643169796232 00643169796287 00763000547325 00643169796300 00763000547257 Serial/Lot numbers C112511 C113253 C113795 C117416 C117482 C121084 C123953 C133327 C133329 C134478 C138060 C150325
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- Abre™ AB9U14080090Medtronic, Inc. · Stent, iliac vein2 recalls9 reports
- Abre™ AB9U12060090Medtronic, Inc. · Stent, iliac vein1 recall4 reports
- Abre™ AB9U14060090Medtronic, Inc. · Stent, iliac vein1 recall4 reports
- Abre™ AB9U14100090Medtronic, Inc. · Stent, iliac vein1 recall4 reports
Product lines
Other devices under the same FDA submission
22 devices cleared under P200026 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Abre™ AB9U16080090Medtronic, Inc. · Stent, iliac vein1 recall6 reports
- Abre™ AB9U18100090Medtronic, Inc. · Stent, iliac vein1 recall2 reports
- Abre™ AB9U16150090Medtronic, Inc. · Stent, iliac vein15 reports
- Abre™ AB9U14150090Medtronic, Inc. · Stent, iliac vein10 reports
- Abre™ AB9U14120090Medtronic, Inc. · Stent, iliac vein8 reports
- Abre™ AB9U16100090Medtronic, Inc. · Stent, iliac vein7 reports
- Abre™ AB9U16120090Medtronic, Inc. · Stent, iliac vein7 reports
- Abre™ AB9U12100090Medtronic, Inc. · Stent, iliac vein5 reports
- Abre™ AB9U16060090Medtronic, Inc. · Stent, iliac vein5 reports
- Abre™ AB9U18060090Medtronic, Inc. · Stent, iliac vein1 death5 reports
- Abre™ AB9U18120090Medtronic, Inc. · Stent, iliac vein5 reports
- Abre™ AB9U12120090Medtronic, Inc. · Stent, iliac vein4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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