Device recall: Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.

Class II FDA enforcement event 89140. Recall start date: 19 Nov 2021. Status in the FDA record: Terminated. Termination date: 16 Aug 2024.

Reason for recall, in the words of FDA

There have been reports of 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., Cardiac Rhythm and Heart Failure (CRHF) started this device recall on 19 Nov 2021. The firm address in the FDA record is in Mounds View, MN. FDA put the recall in Class II. FDA event 89140 has 1 product record. The first FDA enforcement report date is 12 Jan 2022. The record gives the status Terminated, with the termination date 16 Aug 2024.

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.

Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands,…

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, 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 89140: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0464-2022	Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.	21,653 devices	Class II	Terminated	12 Jan 2022

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 2021: 900
Share of these events in Class II: 89%
Product records in this event: 1Median of the firm: 2
Events of the firm on the register: 30

Other events of the firm

Other FDA enforcement events of Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initiated	Product (first record)	Type	Class	Records
10 May 2023	ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators	Device	Class I	120
22 Jun 2022	Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC	Device	Class I	6
20 Apr 2022	The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,	Device	Class II	1
12 Apr 2022	Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA	Device	Class II	2
18 Jan 2022	LINQ II Insertable Cardiac Monitor	Device	Class II	1
8 Nov 2021	Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72	Device	Class II	2
12 Oct 2021	Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Cr	Device	Class II	1
9 Sep 2021	C315-HIS Delivery Catheter	Device	Class II	1
1 Jun 2021	Medtronic Reveal LINQ LNQ11 / PA96000	Device	Class II	1
14 May 2021	Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only	Device	Class II	1

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): all 30 events

Official channels

FDA enforcement report Z-0464-2022The 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 89140. https://recallregister.com/fda/ii/89140/. 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: Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Argentina, Australia, Austria, Bahrain, Belgium, Botswana, Bulgaria, Canary Islands,…
What quantity of product is in FDA event 89140?: The FDA record gives this quantity: 21,653 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2021 have the same class?: 89% of the 900 device events that started in 2021 are in Class II.