Food, drugs, devices › Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Device recall: Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer

FDA enforcement event 84026 · Class II · initiated 3 Oct 2019 · status Ongoing

DeviceVoluntary: Firm initiated3 product recordsMounds View, MN

FDA enforcement event 84026 is a device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) of Mounds View, MN, initiated 3 Oct 2019 and classified Class II, with 3 product records.

FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has 30 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN.

Reason for recall

"There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality."

Distribution

"Worldwide Distribution"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0239-2020	Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer	29544 units	Class II	Ongoing	6 Nov 2019
Z-0240-2020	Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer	6713 units	Class II	Ongoing	6 Nov 2019
Z-0241-2020	Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager	874 units	Class II	Ongoing	6 Nov 2019

Context

88%of 2019 device events are Class II968 events that year

3product records in this eventfirm median: 2

30events on this register for the firm

Other enforcement events for 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
19 Nov 2021	Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.	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

All 30 events for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.