PARADIGM® REAL-time MMT-722LNAS (UDI 00613994287212)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994287212), received between Jul 13, 2017 and Oct 30, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

14 other recalls cover devices cleared under the same FDA submission (P980022); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2018No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE INSULIN PUMP WAS NOT WORKING AND HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 4.4 MMOL/L AT THE TIME OF THE INCIDENT. THE CUSTOMER INSERTED A NEW BATTERY AND THE DISPLAY RETURNED. CUSTOMER WAS ADVISED TO REMOVE THE BATTERY AND REINSERT IT AFTER CLEANING THE BATTERY CAP. THE DISPLAY DID NOT RETURN AFTER REINSERTING THE BATTERY. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8017904 ↗
• InjuryJul 13, 2017Detachment Of Device Component

  THE CUSTOMER REPORTED THAT HER INFUSION SETS ARE DETACHING. THE CUSTOMER STATES THAT SHE INSERTS AND HER PANTS TOUCH THE TUBING AND IT DETACHES. THE CUSTOMER STATES THAT SHE HAS HIGH BLOOD SUGAR AND KETONES AND WILL BE GOING TO THE HOSPITAL. BUT THEN DECIDED LATER THAT SHE WILL TRY AND TREAT HER HIGH BLOOD SUGAR HERSELF OR GO TO A CLINIC INSTEAD OF THE HOSPITAL. THE CUSTOMER STATES THAT ON (B)(6) 2017 HER BLOOD SUGAR STARTED GOING HIGH AND BOLUSING WAS NOT HELPING DUE TO DETACHMENT SO SHE STARTED GIVING HERSELF INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S BLOOD SUGAR IS 497 MG/DL.

  Patient problems: Hyperglycemia

  MAUDE report 6712766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980022. One submission often covers many models, so check the product and lot details in each record.

• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1256-2025 · Jan 31, 2025 · Open, Classified
  Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-2442-2015 · Jul 22, 2015 · Terminated
  Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with d
• Z-2179-2014 · Jul 21, 2014 · Terminated
  Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combinatio
• Z-2544-2014 · Mar 13, 2014 · Terminated
  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