FDA Medical Device Recalls (openFDA)
Medtronic MiniMed: Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Recall number
- Z-1587-2020
- Recalling firm
- Medtronic MiniMed
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Status
- Open, Classified
- Initiated
- 2019-06-27
- Posted
- 2020-03-26
- Terminated
- not on file
- 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. . 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.
- Quantity
- 88,243
- Distribution
- US nationwide distribution including Puerto Rico.
- Lot, serial or model codes
- All software versions
- 510(k) numbers
- not on file
- PMA numbers
- ["P980022"]
- Product code
- OYC
- Firm FEI
- 3003166194
- Firm city
- Northridge
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28