FDA Medical Device Recalls (openFDA)
Medtronic MiniMed Inc.: Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
- Recall number
- Z-2544-2014
- Recalling firm
- Medtronic MiniMed Inc.
- Product
- Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
- Status
- Terminated
- Initiated
- 2014-03-13
- Posted
- 2014-08-22
- Terminated
- 2015-04-07
- Reason
- Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.
- Root cause
- Device Design
- Action
- The firm, Medtronic, sent an "IMPORTANT MEDICAL DEVICE SAFETY INFORMATION" letter dated March 13, 2014 to its customers. The letter described the product, problem and actions to be taken. The letter informs the customers that because accidental button pressing errors may occur it is important that customers always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. The letter informs the customers of what safety settings will minimize the risk of an accidental programming error and what actions to be taken. Should you have any questions about this letter or concerns with your keypad, please do not hesitate to contact the 24 hour helpline at (866) 222-7304 for a replacement.
- Quantity
- 559,374 units total (444,374 units in US)
- Distribution
- Worldwide Distribution-Nationwide in US
- Lot, serial or model codes
- Paradigm: MMT-523NAB, MMT-723KNB, MMT-523NAH, MMT-723KNH, MMT -523NAL, MMT-723KNL, MMT-523NAP, MMT-723KNP, MMT-523NAS, MMT-723KNS, MMT-723NAB, MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH, MMT-523KNL, MMT-523KNP, MMT-523KNS. MiniMed 530G: MMT-551NAM, MMT-551NAH, MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL, MMT-751NAP, MMT-751NAS.
- 510(k) numbers
- not on file
- PMA numbers
- ["P980022","P120010"]
- 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