Food, drugs, devices › Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Device recall: Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) (Mounds View, MN) initiated this device recall on 30 Jan 2020; FDA lists 2 product records under event 84944, classified Class II.
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. 93% of the 916 device enforcement events initiated in 2020 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
"Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information."
Distribution
"Worldwide distribution. US Nationwide including Puerto Rico, Argentina, Brazil, Colombia, Trinidad and Tobago, Venezuela, Dominican Republic, Bahamas, Peru, Bermuda, Barbados, Ecuador, Cayman…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1524-2020 | Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT. | 23,180 devices | Class II | Ongoing | 25 Mar 2020 |
| Z-1525-2020 | Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT. | 5,540 devices | Class II | Ongoing | 25 Mar 2020 |
Context
Other enforcement events for Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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: "Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information."
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. US Nationwide including Puerto Rico, Argentina, Brazil, Colombia, Trinidad and Tobago, Venezuela, Dominican Republic, Bahamas, Peru, Bermuda, Barbados, Ecuador, Cayman…"
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.