Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): FDA recalls

FDA enforcement reports name Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) as the recalling firm in 30 events. The events have 198 product records. The recalls started from 2017 to 2023. All the events are device recalls.

See the 30 events

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.

Enforcement events

30 events, newest first.

FDA enforcement events of Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Initiated	Product (first record)	Type	Class	Records	Status
10 May 2023	ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators	Device	Class I	120	Ongoing
22 Jun 2022	Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4	Device	Class I	6	Ongoing
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, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable catheter. The…	Device	Class II	1	Ongoing
12 Apr 2022	Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DVPA2D4; b) Cobalt VR: DVPB3D1, DVPB3D4; c) Cobalt XT DR: DDPA2D1, DDPA2D4; d) Cobalt DR: DDPB3D1, DDPB3D4; e) Cobalt XT HF: DTPA2D4, DTPA2D1 f) Cobalt HF: DTPB2D4, DTPB2D1; g) Cobalt XT HF Quad:…	Device	Class II	2	Ongoing
18 Jan 2022	LINQ II Insertable Cardiac Monitor	Device	Class II	1	Terminated
19 Nov 2021	Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.	Device	Class II	1	Terminated
8 Nov 2021	Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72	Device	Class II	2	Terminated
12 Oct 2021	Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR: DVPB3D1, DVPB3D4; Cobalt XT DR: DDPA2D1,…	Device	Class II	1	Ongoing
9 Sep 2021	C315-HIS Delivery Catheter	Device	Class II	1	Ongoing
1 Jun 2021	Medtronic Reveal LINQ LNQ11 / PA96000	Device	Class II	1	Ongoing
14 May 2021	Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only	Device	Class II	1	Ongoing
7 Apr 2021	Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and…	Device	Class II	1	Terminated
6 Apr 2021	CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).	Device	Class II	2	Ongoing
6 Apr 2021	Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure. 1. Azure family: Azure XT DR MRI SureScan", Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR…	Device	Class II	4	Ongoing
3 Feb 2021	Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs)…	Device	Class I	2	Ongoing
15 Nov 2020	Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)	Device	Class II	3	Terminated
5 Nov 2020	Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)	Device	Class II	1	Ongoing
4 Jun 2020	CareLink SmartSync Device Manager, Model Number 24970A	Device	Class II	9	Ongoing
30 Jan 2020	Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.	Device	Class II	2	Ongoing
3 Oct 2019	Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer	Device	Class II	3	Ongoing
6 Aug 2019	Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.	Device	Class II	2	Terminated
4 Mar 2019	Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic Atrial Fibrillation (AF). The PVAC GOLD…	Device	Class III	1	Ongoing
17 Jan 2019	Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01	Device	Class I	7	Ongoing
17 Jan 2019	MEDTRONIC CARELINK 2090 programmer	Device	Class II	2	Terminated
17 Jan 2019	Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer	Device	Class II	1	Terminated
2 Oct 2018	Medtronic CareLink 2090 Programmer	Device	Class II	2	Ongoing
21 Jun 2018	Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable…	Device	Class II	6	Terminated
21 Jun 2018	Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing,…	Device	Class II	4	Terminated
6 Jun 2018	Single Chamber Temporary External Pacemaker, Model 53401	Device	Class II	1	Terminated
19 Dec 2017	Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) Implantable…	Device	Class I	8	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

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

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

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Type and class

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): events for each product type
Type		Events
Device		30

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): events in each class
Class		Events
Class II		24
Class I		5
Class III		1

Share of the events of the firm in Class I: 17%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 18

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.

Events by year

FDA enforcement events of Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), by the year that the recall started. The largest year is 2021, with 10 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): FDA recalls. https://recallregister.com/firm/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: MN

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) have?: Class II: 24 events. Class I: 5 events. Class III: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)?: FDA event 92328, which the firm started on 10 May 2023. The first product in the record is: ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
How many FDA recalls of Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) have the status Ongoing?: 18 events have the status Ongoing in the openFDA file. openFDA says 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.