Food, drugs, devices › Medtronic Inc.
Device recall: MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these
FDA enforcement event 76436 is a device recall by Medtronic Inc. of Northridge, CA, initiated 31 Jan 2017 and classified Class II, with 1 product record.
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 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 4 May 2017. Initiation: voluntary: firm initiated. Medtronic Inc. has 47 enforcement events on this register, with a median of 1 product record 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., Northridge, CA.
Reason for recall
"Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown."
Distribution
"Europe, Australia, Japan, Singapore"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1890-2017 | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712. | 42,215 units | Class II | Terminated | 10 May 2017 |
Context
Other enforcement events for Medtronic Inc.
All 47 events for Medtronic Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown."
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: "Europe, Australia, Japan, Singapore"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 May 2017. "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.