Food, drugs, devices › Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Device recall: Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) (Mounds View, MN) initiated this device recall on 17 Jan 2019; FDA lists 1 product record under event 81950, 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 30 Mar 2021. 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 an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some…"
Distribution
"US and Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0845-2019 | Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer | 731 units | Class II | Terminated | 27 Feb 2019 |
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: "There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some…"
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: "US and Armenia, Bulgaria, Croatia, Georgia, Hungary, India, Iran, Jordan, Kazakhstan, Latvia, Lebanon, Oman, Pakistan, Qatar, Romania, Saudi Arabia, Syrian Arab Republic"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Mar 2021. "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.