Device recall: Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090…

Class II FDA enforcement event 98157. Recall start date: 4 Dec 2025. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Medtronic Inc started this device recall on 4 Dec 2025. The firm address in the FDA record is in Plymouth, MN. FDA put the recall in Class II. FDA event 98157 has 1 product record. The first FDA enforcement report date is 21 Jan 2026. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia,…

Recalling firm

Medtronic Inc, Plymouth, MN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 98157: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1098-2026	Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090	442	Class II	Ongoing	21 Jan 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2025: 945
Share of these events in Class II: 85%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 47

Other events of the firm

Other FDA enforcement events of Medtronic Inc
Initiated	Product (first record)	Type	Class	Records
11 Mar 2026	Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial f	Device	Class II	1
29 Oct 2025	Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product	Device	Class II	1
18 Jun 2025	Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Cro	Device	Class II	2
17 Jun 2025	Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software compo	Device	Class II	2
29 Apr 2025	Azure S DR MRI SureScan, Product number W3DR01	Device	Class II	1
11 Jul 2024	2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE	Device	Class II	1
16 Apr 2024	COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator	Device	Class II	23
16 Feb 2024	Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090	Device	Class II	1
7 Dec 2023	Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1	Device	Class II	1
20 Nov 2023	Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.	Device	Class II	1

Medtronic Inc: all 47 events

Official channels

FDA enforcement report Z-1098-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 98157. https://recallregister.com/fda/ii/98157/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia,…
What quantity of product is in FDA event 98157?: The FDA record gives this quantity: 442
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2025 have the same class?: 85% of the 945 device events that started in 2025 are in Class II.