PARADIGM® REAL-time MMT-522NAS (UDI 00613994271440)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994271440), received between Jun 7, 2017 and Feb 25, 2020 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT CONTINUES TO DRIP AFTER MOTOR STOPS DURING THE MANUAL PRIME PROCESS. DIVE SUPPORT CAP WAS STICKING OUT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9749878 ↗
• MalfunctionFeb 17, 2020Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED MULTIPLE MOTOR ERROR ALARM. CUSTOMER STATED THAT BATTERY LIFE WAS NOT AS GOOD AS WHEN FIRST RECEIVED GOES FROM 1 BAR TO ZERO OVERNIGHT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9715718 ↗
• MalfunctionAug 14, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP LOCKED UP AND WAS NON RESPONSIVE FOR COUPLE OF TIMES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP DID NOT RECEIVED LOW BATTERY ALERTS ON TIME AND WILL SHUT OFF WITHIN 2 TO 3 HOURS. CUSTOMER ALSO STATED THAT INSULIN PUMP REJECTED NEW BATTERIES FREQUENTLY AND MOTOR MAKES GRINDING NOISES DURING REWIND AS WELL AS RECEIVED UNEXPLAINED NO DELIVERIES SEVERAL TIMES. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8891878 ↗
• MalfunctionApr 24, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. CUSTOMER STATES THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8543195 ↗
• MalfunctionJan 31, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STICKY BUTTONS. THE BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS UNKNOWN. THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN AND THE MOTOR WAS LOUDER TO REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8291896 ↗
• MalfunctionJun 22, 2018Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD PRIME REWIND AND INSULIN SQUIRTED OUT IF THE TUBING DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATES THEY DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629284 ↗
• MalfunctionMar 8, 2018Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 102 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL (RECESSED). THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7325837 ↗
• InjuryNov 8, 2017Component Falling; Fluid/Blood Leak; Looping; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME LOOP AND INSULIN SQUIRTED OUT IF THE TUBING DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE WAS 250 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT INSULIN PUMP WAS DROPPED PRIOR TO ALARM AND DRIVE SUPPORT CAP WAD NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7011334 ↗
• MalfunctionJul 11, 2017Device Displays Incorrect Message

  IT WAS REPORTED THAT THE INSULIN PUMP IS ALARMING AND WILL RECUR AFTER THE REWIND PROCESS. THE CUSTOMER'S BLOOD SUGAR IS 134 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT IS STICKING OUT. THE INSULIN PUMP WILL RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6704651 ↗
• MalfunctionJun 7, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 197 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER RECEIVED THE COMPROMISED FORCE SENSOR SYSTEM ALARM WHILE TRYING TO PRIME THE TUBING AND WILL NOT GET OUT OF PRIMING STAGE. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6620575 ↗

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-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• 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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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