Recall Z-1589-2020 ยท OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Medtronic MiniMed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
| Date | Mar 26, 2020 (initiated Jun 27, 2019) |
| Status | Open, Classified |
| Reason | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery. |
| Root cause | Device Design |
| Action | On June 27, 2019, Medtronic issued an Urgent Field Safety Notification letter via mail and email to its consignees. Medtronic made the decision to renotify customers, and on January 4, 2023, Medtronic issued an Urgent Medical Device Correction - Update letter. The communication asks consignees to take the following actions: .To find the software version for the MiniMed Paradigm pumps, go to the STATUS screen: . To open the STATUS screen, press ESC until the STATUS screen appears. . To view more text on the STATUS screen, press the up or down arrow to scroll and view all the information. |
| Quantity | 38 |
| Distribution | US nationwide distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.