Z-1317-2024Class II

Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090

Name: Z-1317-2024 Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Creator: Medtronic Inc.
Published: 2024-02-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-02-16 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Inc. began a recall of Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090 on 2024-02-16. FDA classified it as Class II and gives the reason as "There is a potential for sterile package breach". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1317-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-16
Posted: 2024-03-19
Recalling firm: Medtronic, Inc.
Product: Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Product code: QAN Stent, Iliac Vein
Reason for recall: There is a potential for sterile package breach.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic issued and URGENT: MEDICAL DEVICE RECALL notice to it consignees on 02/16/2024 via FedEx. The notice explained the issue and requested the consignee immediately remove, and quarantine all impacted devices pending a follow-up communication providing additional information pertaining to product retrieval for this issue within 2-3 weeks.
Quantity in commerce: 65 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.
Product codes and lots: a) AB9U14080090, UDI/DI 00643169796294, Batch Number B456626; b) AB9U18100090, UDI/DI 00643169796409, Batch Number B456811; c) AB9G14100090, IUDI/DI 00763000547325, Batch Number B460542

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1317-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1317-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19

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)