Z-1532-2021Class II

Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 -

Name: Z-1532-2021 Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 -
Creator: Medtronic Inc.
Published: 2021-03-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-03-16 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. began a recall of Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment... on 2021-03-16. FDA classified it as Class II and gives the reason as "Incorrect size printed on the device; packaging is labeled correctly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1532-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-16
Posted: 2021-05-05
Terminated: 2024-04-15
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: QAN Stent, Iliac Vein
Reason for recall: Incorrect size printed on the device; packaging is labeled correctly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 23 devices
Distribution: US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
Product codes and lots: UDI 00643169796348, Lot Number B086915

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1532-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1532-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-12	2021-05-05

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)