Abre recallZ-1532-2021 · Medtronic Inc. · initiated Mar 16, 2021
Terminated
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
Incorrect size printed on the device; packaging is labeled correctly.
FDA root cause category: Process control
What the company is doing
Beginning 16-Mar-2021, Medtronic initiated verbal communications to consignees in possession of affected units. Consignees were advised to quarantine all affected units within their possession, pending retrieval. A written Medical Device Correction letter was mailed on 03/30/2021 via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. Consignees are also asked to return all unused, affected product within their possession.
Recall details
- Recall number
- Z-1532-2021
- Status
- Terminated
- Initiated by the company
- Mar 16, 2021
- Recalling firm
- Medtronic Inc.
- Quantity
- 23 devices
- Product code
- QAN
- FDA submissions
- P200026
- Distribution
- US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
Product description
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Code information (models, lots, serial numbers)
UDI 00643169796348, Lot Number B086915
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Abre™ AB9U16080090Medtronic, Inc. · Stent, iliac vein1 recall6 reports
Product lines
Other devices under the same FDA submission
25 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™ 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
- 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
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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