PARADIGM® REAL-time MMT-722LNALRecalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00613994409539), received between Jun 1, 2017 and Jul 20, 2021 — classified as 1 death, 52 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (33 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. 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 25 most recent of 170 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2021Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A RECURRING MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE DEVICE WAS NOT EXPOSED TO STRONG MAGNETIC FIELD AND THE DRIVE SUPPORT CAP APPEARED NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 12194653 ↗
• MalfunctionJul 22, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTON DID NOT FUNCTIONS PROPERLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT INSULIN HAD CRACKED AROUND OUTSIDE AND SCREEN WAS DIM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10307000 ↗
• MalfunctionJul 15, 2020Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM AND KEYPAD ANOMALY. CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM. BUTTONS WERE NOT RESPONDING. 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 10275594 ↗
• InjuryJul 10, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 571 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER WAS ABLE TO CLEAR ALARM. THE DEVICE WILL BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR.

  Patient problems: Hyperglycemia

  MAUDE report 10256324 ↗
• MalfunctionJul 1, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER STATED THAT THE BUTTONS WERE HARD TO WORK. CUSTOMER STATED THAT THE INSULIN PUMP WAS SLOWER DURING REWIND. INSULIN PUMP SCREEN WAS SCRATCHED AND AFFECT VISIBILITY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10216872 ↗
• MalfunctionJun 23, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Insufficient Device Problem Information; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNRESPONSIVE KEYPAD. CUSTOMER STATED INSULIN PUMP REJECTED NEW BATTERIES AND HAD SCRATCHES OR DAMAGE ON THE DISPLAY WITH RAINBOW EFFECT MAKING IT HARD TO READ. CUSTOMER STATED INSULIN PUMP HAD UNUSUAL GRINDING NOISES DIFFERENT FROM THE NORMAL REWIND NOISES. CUSTOMER STATED INSULIN PUMP HAD AN UNEXPLAINED NO DELIVERY ALARM MULTIPLE TIMES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10185798 ↗
• MalfunctionJun 5, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THAT THE INSULIN PUMP WAS STUCK IN REWIND COMPLETE OR BOLUS DELIVERY LOOP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 10122244 ↗
• InjuryJun 3, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH SHOT. THE CUSTOMER WAS REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10117370 ↗
• MalfunctionMay 14, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS ALERTING A BUTTON ERROR. THE CUSTOMER STATED TAT THE TIME ON THE INSULIN PUMP ADVANCED. 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 10055141 ↗
• MalfunctionApr 20, 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 INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ERROR. CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THAT THE DRIVE 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 9979149 ↗
• MalfunctionApr 17, 2020Premature Discharge of Battery; Unauthorized Access to Computer System; Premature Discharge of Battery; Unauthorized Access to Computer System

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARMS. THE CUSTOMER ALSO MADE A CYBER SECURITY- HACKING ALLEGATION. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL BE RECEIVING AN UPGRADED INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9975520 ↗
• MalfunctionApr 8, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DOWN ARROW WAS NOT WORKING WELL AND INSULIN PUMP CHIPPED WHERE RESERVOIR GOES. IT WAS ALSO REPORTED THAT THE INSULIN PUMP DID NOT REWIND ALL THE WAY. THE CUSTOMER STATED THAT THE RESERVOIR LOCK INTO PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9936402 ↗
• InjuryApr 1, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE VISITED TO EMERGENCY ROOM THEN HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON MARCH 22, 2020. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 20 MG/DL,28 MG/DL,150 MG/DL. THE CUSTOMER WAS TREATED BY FOOD AND GLUCAGON. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. BASED ON CUSTOMER REPORT CUSTOMER DID ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER ALSO REPORTED THAT IT HAD BEEN GIVING INSULIN WITHOUT ME PRESSING ANYTHING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9909159 ↗
• InjuryApr 1, 2020Excess Flow or Over-Infusion; No Apparent Adverse Event; Excess Flow or Over-Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE IN THE EMERGENCY ROOM AND THEN HOSPITALIZED FOR THE LOW BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 20 MG/DL WHICH WAS TREATED WITH THE GLUCAGON. THE CUSTOMER REPORTED THAT INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER REPORTED THAT INSULIN PUMP GIVING INSULIN WITHOUT CUSTOMER PRESSING ANYTHING. THE CUSTOMER REPORTED THAT THIS WAS THE 4TH TIME WERE THE BLOOD GLUCOSE DROPPED TO 20 MG/DL. IT WAS UNKNOWN WHETHER CUSTOMER WAS USING THE AUTO MODE OR NOT. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9909090 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS DIFFICULTY IN BREATHING AND DIABETIC KETO ACIDOSIS. CUSTOMER UNABLE TO PROCEED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Dyspnea; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 9846372 ↗
• InjuryMar 17, 2020Communication or Transmission Problem; Detachment of Device or Device Component; Patient Device Interaction Problem; Communication or Transmission Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER HAD A PROBLEM WITH THE PLUNGER ON THE BACK OF THE RESERVOIR THAT WAS STICKING OUT, STATED THAT THERE WERE A CRACK AROUND THE RESERVOIR WINDOW, 3 TO 4 OF AN INCH BY THE RESERVOIR COMPARTMENT AND DRIVE SUPPORT CAP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9840712 ↗
• MalfunctionMar 3, 2020Computer Software Problem; No Display/Image; Power Problem; Computer Software Problem; No Display/Image; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPLETELY DIED, SCREEN WAS FROZEN AND HAD ALARM MESSAGES. 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 9778384 ↗
• MalfunctionJan 20, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND THEY WERE UNABLE TO REWIND INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. 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 9605489 ↗
• MalfunctionJan 14, 2020Material Integrity Problem; Patient Device Interaction Problem; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S DISPLAY SCREEN WAS CRACKED, O RING ON THE RESERVOIR COMPARTMENT WAS BROKEN AND ALSO CRACKED AND THE BATTERY DID NOT CLICK INTO THE BATTERY COMPARTMENT PROPERLY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9585883 ↗
• MalfunctionJan 12, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ACCT POSSIBLE OVER DELIVERY HIGHS AND LOWS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 182 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH AND LOW ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 9579644 ↗
• MalfunctionJan 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP BUTTON ARE NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 212MG/DL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552855 ↗
• MalfunctionNov 22, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD REJECTED NEW BATTERIES, RANDOM NO DELIVERY ALARMS, CRACK NEAR SCREEN AND BUTTONS WERE STUCK ALL THE TIME DOES NOT REACT TO FINGER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9360587 ↗
• MalfunctionOct 16, 2019Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM WHEN PRIMING AND INSULIN EVER SQUIRT OUT INSTEAD OF DRIP. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP HAD SCRATCHED ON THE SCREEN AND MECHANICAL ISSUE. CUSTOMER STATED THE THEY SAW PUMP ERROR ALARM OTHER THAN LOW BATTERY AND LOW RESERVOIR. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9196186 ↗
• MalfunctionOct 16, 2019No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARM WITH BUTTON ERROR AS WELL AS THE INSULIN PUMP WAS NOT WORKING. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE TIME CLOCK WAS ADVANCE FOR ONE MINUTE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9196087 ↗
• MalfunctionOct 14, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERRORS AND WOULD NO LONGER DELIVER INSULIN. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER DECLINED TO SPEAK WITH TECHNICAL SUPPORT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9184891 ↗

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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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