PARADIGM® REAL-time MMT-722NAS (UDI 00613994223746)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00613994223746), received between Jun 28, 2017 and Mar 28, 2020 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE HARD TO WORK, CRACK ON FRONT OF THE SCREEN AND INSULIN PUMP HAD NO LIVERY ALARM. 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 9892642 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE ON TWO OCCASIONS DUE TO LOW BLOOD GLUCOSE WITH BLOOD GLUCOSE OF 30 TO 40 MG/DL AT THE TIME OF ONE OF THE INCIDENTS. THE CUSTOMER WAS IN THE 100 MG/DL RANGE AFTER BEING TREATED. THE CUSTOMER WAS GIVEN SODA TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS SWEATING AND INABILITY TO GET UP. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER WAS USING A DIFFERENT PUMP AT THE TIME OF THE CALL. THE CUSTOMER WAS PERFORMING SET CHANGES AFTER 7 DAYS INSTEAD OF THE RECOMMENDED 3. THE CUSTOMER WAS ALSO USING THE RECALLED INFUSION SETS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9556414 ↗
• MalfunctionSep 27, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9127823 ↗
• MalfunctionJul 29, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART, A COLD RESET WAS PERFORMED ALARM AND MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALERTS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE ALARM HAPPENED AFTER REPLACE A BATTERY. CUSTOMER STATED THAT THIS WAS THE FIRST TIME THAT THE CUSTOMER RECEIVED AN ERROR. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8835603 ↗
• MalfunctionJul 25, 2019Failure to Cycle; Priming Problem; Failure to Cycle; Priming Problem

  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. THE CUSTOMER STATED THAT THEY ARE UNABLE TO EXIT THE PREPARED TO PRIME LOOP. 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 8826403 ↗
• MalfunctionJul 25, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WOULD NOT ALLOW PRIMING PROCESS TO COMPLETE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE SCREW BY THE BATTERY COMPARTMENT WAS CRUMBLING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8825837 ↗
• MalfunctionJun 4, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666384 ↗
• MalfunctionMay 22, 2019No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem; No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTONS HARDER TO PRESSING AND SCREEN WENT BLACK A COUPLE OF TIMES. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THEY RECEIVED FREQUENT UNEXPLAINED NO DELIVERY ALARMS, RAINBOW EFFECT OCCASIONALLY ON SCREEN, BUTTONS ARE WORN, COULD NOT SEE ESC UP AND DOWN LETTERING, CRACK ON RESERVOIR SCREEN AND SCRATCHES ON BODY AND SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8630612 ↗
• InjuryDec 7, 2018Adverse 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 THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 497 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8140939 ↗
• MalfunctionNov 22, 2018Failure to Cycle; Detachment of Device or Device Component; No Apparent Adverse Event; Patient Device Interaction Problem; Failure to Cycle; Detachment of Device or Device Component; No Apparent Adverse Event; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPRISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS PROTRUDED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098497 ↗
• InjuryOct 19, 2018Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 500 MG/DL. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS OR TREATMENT OF THEIR HIGH BLOOD GLUCOSE EPISODES. THE CUSTOMER ALSO REPORTED THAT THE BUTTONS REQUIRED MULTIPLE PRESSES TO WORK, UNEXPLAINED NO DELIVERY ALARM AND MOTOR REWIND ISSUE. THE CUSTOMER DECLINED TO TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7985361 ↗
• MalfunctionSep 27, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THERE WERE ISSUES ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A STREAM DURING PRIMING AND RAINBOW EFFECT ON THE THE DISPLAY SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7914840 ↗
• MalfunctionSep 7, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN UNEXPECTED ALARM DURING NORMAL USE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE INSULIN PUMP WAS STUCK ON REWIND AND COULD NOT GET TO HISTORY. THE CUSTOMER STATED THE ALARM OCCURRED DURING THE REWIND/PRIME SEQUENCE. THE CUSTOMER WAS ADVISED TO REFER TO BACK-UP PLAN, PER HEALTHCARE PROFESSIONAL'S INSTRUCTIONS. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849864 ↗
• MalfunctionAug 31, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL GENERAL UNEXPECTED RESTART ALARM ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 235 MG/DL. TROUBLESHOOTING FOR THE GENERAL UNEXPECTED RESTART ALARM WAS PERFORMED. CUSTOMER REPLACED THE BATTERY ON THE INSULIN PUMP MULTIPLE TIMES AND THE ISSUE REMAINED UNRESOLVED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6837026 ↗
• MalfunctionJul 27, 2017Application Interface Becomes Non-Functional Or Program Exits Abnormally; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP FROZE AND GOT A BUTTON ERROR ALARM, AND AFTER CHANGING THE BATTERY, IT STARTED WORKING AGAIN BUT PUSHES OUT 40 UNITS BEFORE IT HITS THE END OF THE SYRINGE, AND THEN A COMPROMISED FORCE SENSOR SYSTEM ALARM OCCURS AND KEEPS REPEATING AFTER THE REWIND . THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATES THE PUMP'S DRIVE SUPPORT CAP IS STICKING OUT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6749257 ↗
• InjuryJun 28, 2017Break; Detachment Of Device Component; Component Falling; Device Displays Incorrect Message

  CUSTOMER CALLED AND REPORTED THAT THEY GOT ADMITTED TO A HOSPITAL DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE BELOW 20 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS EXPERIENCING A MOTOR ERROR ALARM AND A COMPROMISED FORCE SENSOR SYSTEM ALARM 1 TO 10 DAYS AFTER THE PUMP WAS DROPPED. THE PUMP'S CASING POPPED OFF ON THE MOTOR SIDE. THE CUSTOMER WAS GIVEN INTRAVENOUS FLUIDS AND FOOD TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS A SEIZURE. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED FOR THE COMPROMISED FORCE SENSOR SYSTEM ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6675359 ↗

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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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