Recall Z-1585-2020
Medtronic MiniMed · initiated June 27, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
Codes / lots: All software Versions Available outside the US only.
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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. . To exit the STATUS screen, press ESC until the STATUS screen disappears. ACTIONS REQUIRED: 1. Review and take the following cybersecurity precautions listed below. 2. Please complete and sign the customer confirmation form attached as indicated and return by mail using the attached prepaid envelope. You can also email this form to our Field Corrective Action Department at rs.safetyinformation@medtronic.com or send via fax to 1-888-844-8084 to the attention of FCA Department.
Details
- Recall number
- Z-1585-2020
- Initiated
- June 27, 2019
- Posted by FDA
- March 26, 2020
- Product code
- LZG – Pump, Infusion, Insulin
- Quantity
- 36,143
- Distribution
- US nationwide distribution including Puerto Rico.
- Recalling firm
- Medtronic MiniMed, Northridge, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1581-2020 Class II | MiniMed Insulin Pump, model # MMT-508The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1582-2020 Class II | MiniMed Paradigm Model 511 Insulin PumpThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1583-2020 Class II | MiniMed Paradigm 512 Insulin pumpThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1584-2020 Class II | MiniMed Paradigm Insulin pump, model number MMT-712The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1586-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1587-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-522The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1588-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-722The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1589-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-522KThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1590-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-722KThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1591-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-523The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1592-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-523KThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1593-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-723KThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1594-2020 Class II | Medtronic MiniMed Paradigm Insulin pump, model number MMT-723The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1595-2020 Class II | Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |
| Z-1596-2020 Class II | Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CMThe action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin… | 06/27/2019Open, Classified |