Paradigm® REAL-Time Revel™ MMT-523NAH (UDI 00643169693739)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169693739), received between Mar 16, 2018 and Dec 19, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

14 other recalls cover devices cleared under the same FDA submission (P150019, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2018Mechanical Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT PUMP SAYS REWIND COMPLETE BUT RESERVOIR WILL NOT FIT INTO PUMP. THE BLOOD GLUCOSE LEVEL WAS 259MG/DL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8177964 ↗
• MalfunctionJul 18, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP REJECT THE BATTERIES AND RANDOM UNEXPECTED NO DELIVERY ALARMS . THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7700704 ↗
• MalfunctionMar 16, 2018Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED FOR BATTERY FAILED AFTER CLEARING EMPTY RESERVOIR. CUSTOMER PERFORMED TROUBLESHOOT FOR ISSUE BUT INSULIN PUMP AGAIN RECEIVED FAILED BATTERY TEST. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP WAS WHISTLING AND PULSATING BEFORE THE ALARM. INSULIN PUMP WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344391 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, 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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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