PARADIGM® REAL-time MMT-722NAS (UDI 00613994312587)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-722NAS PRDGM V2.2 SK EN PR LK · Class 3
All models of PARADIGM REAL-time (95)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic MiniMed Paradigm insulin pump, a body-worn device that delivers insulin continuously. The 27 reports mostly describe the pump failing to cycle or prime, buttons and screens not responding, error alarms, and batteries being rejected; a few describe insulin squirting out during manual priming, and some patients reported high blood sugar. One report describes a death and 2 describe injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00613994312587), received between Jun 12, 2017 and Aug 3, 2020 — classified as 1 death, 2 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Failure to Cycle” (8 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
Device problems
- Failure to Cycle8
- Device Difficult to Program or Calibrate5
- Adverse Event Without Identified Device or Use Problem4
- Patient Device Interaction Problem3
- Power Problem3
- Priming Problem3
- Detachment of Device or Device Component2
- Device Displays Incorrect Message2
Patient problems
- No Consequences Or Impact To Patient23
- Hyperglycemia3
- Death1
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED BUTTON ERROR. CUSTOMER TOOK BATTERY OUT BUT SAME ERROR OCCURRED. 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 10360345 ↗MalfunctionAug 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. TROUBLESHOOTING WAS DONE FOR BUTTON ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT STILL BUTTONS 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 10355561 ↗MalfunctionJul 14, 2020Failure to Cycle; Power Problem; Patient Device Interaction Problem; Priming Problem; Failure to Cycle; Power Problem; Patient Device Interaction Problem; Priming Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SQUIRTING OUT INSULIN. THE CUSTOMER STATED THE DEVICE HAD WEAR AND TEAR OVER THE SCREEN AND BUTTONS. INSULIN PUMP HAD REJECTED BATTERIES. 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 10270434 ↗MalfunctionApr 23, 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. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 316 MG/DL AND TREATED IT WITH MANUAL SHOTS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9990452 ↗InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8987927 ↗MalfunctionAug 29, 2019Priming Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. 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 DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8944259 ↗MalfunctionAug 8, 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 130 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THAT THEY WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWOUND. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8872960 ↗MalfunctionJul 8, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PRIME ANOMALY AND INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. AND DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 160 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8766344 ↗MalfunctionJun 11, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WILL SHOOT OR SQUIRT INSULIN OUT DURING PRIMING AS OPPOSED TO DRIPPING AND BUTTONS WERE HARDER TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP RECEIVES RANDOM UNEXPLAINED NO DELIVERY ALERTS AND ALSO REJECTED NEW BATTERIES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8686031 ↗MalfunctionMay 28, 2019Device Difficult to Program or Calibrate; No Apparent Adverse Event; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE ACT, ESC, UP, DOWN, AND B BUTTONS WERE NOT WORKING. THE CUSTOMER ALSO REPORTED THAT THERE WERE CRACKS NEAR THE RESERVOIR OPENING AND BY THE BUTTONS AND SYSTEM WAS POWERING DOWN. THE INSULIN PUMP HAD SUSPENDED UNEXPECTEDLY RELATED TO CARELINK UPLOAD. 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 8644551 ↗InjuryMay 17, 2019Adverse 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 WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS ON UNKNOWN DATE WITH BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS 126 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 12 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 8618644 ↗MalfunctionMay 8, 2019Premature Discharge of Battery; Failure to Cycle; Premature Discharge of Battery; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM WHILE PRIMING AND A NO DELIVERY/OCCLUSION ALARM DURING THERAPY ALARM WHILE CHANGING THE BATTERY OUT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 121 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. IT WAS REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE 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 8590179 ↗MalfunctionMar 27, 2019No Display/Image; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; No Display/Image; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND AFTER BATTERY PUT IN GETS BATTERY OUT LIMIT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8456348 ↗MalfunctionFeb 20, 2019No Display/Image; Obstruction of Flow; Power Problem; No Display/Image; Obstruction of Flow; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND NO DELIVERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 153 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DISPLAY DID NOT RETURNED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE INSULIN PUMP NEED TO BE REPLACED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8356614 ↗MalfunctionOct 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP BUTTONS NOT RESPONSIVE AND NO DELIVERY ALARMS AND ERROR CODES. 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 7998331 ↗MalfunctionOct 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 129 MG/DL. DRIVE SUPPORT CAP WAS STICKING OUT. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7929290 ↗MalfunctionSep 28, 2018Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S LAST BLOOD GLUCOSE LEVEL WAS 121 MG/DL AND CURRENT BLOOD GLUCOSE WAS 185 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED/ LOOSE/STICKING OUT. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER TROUBLESHOOT WAS PERFORMED. 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 7917486 ↗MalfunctionSep 18, 2018Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MULTIPLE ERROR. CUSTOMER BLOOD GLUCOSE LEVEL WAS 114 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS 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 DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7884085 ↗MalfunctionSep 14, 2018Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 170 MG/DL. THE CUSTOMER STATED THAT THEY HAD RECEIVED MOTOR ERROR AND ALSO RECEIVED CRITICAL PUMP ERROR. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP AND THE SUPPORT CAP STICKING OUT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND RECOMMENDED CUSTOMER REFER TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THAT THE PUMP NEEDS TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7879364 ↗MalfunctionAug 23, 2018Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FAILURE TO CYCLE. 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 THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP IS BEING REPLACED AND NOT EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7810309 ↗MalfunctionJul 9, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 146MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND HAD UNRESPONSIVE BUTTONS. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS NOT ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7670282 ↗MalfunctionMar 23, 2018Device Operates Differently Than Expected
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 148 MG/DL. THE CUSTOMER REPORTED THAT INSULIN PUMP WAS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE CUSTOMER PRESSED ACT ON THE REWIND COMPLETE SCREEN HOWEVER, WAS UNABLE TO EXIT. THE CUSTOMER WAS HELPED TO PERFORM TROUBLESHOOTING FOR CLEARING BATTERY OUT LIMIT ALERT. THE CUSTOMER PERFORMED TROUBLESHOOTING FOR REWIND FILL TUBING PROCESS AND FOUND THAT THE INSULIN PUMP DID NOT EXIT AND THE REWIND COMPLETE BOLUS DELIVERY LOOP AND COMPLETE THE FILL TUBING PROCESS SUCCESSFULLY. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7366605 ↗MalfunctionFeb 27, 2018Device Operates Differently Than Expected
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 184 MG/DL AT THE TIME OF THE INCIDENT. 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 7301636 ↗DeathNov 30, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS UNKNOWN BUT THE CUSTOMER STOPPED BREATHING DURING THE NIGHT. THE CALLER STATED THAT THE CUSTOMER HAD LOTS OF HEALTH ISSUES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS AS IT WAS LOST BY THE PARAMEDICS.
Patient problems: Death
MAUDE report 7071358 ↗MalfunctionSep 19, 2017Leak/Splash; Looping; Failure to Prime; Device Displays Incorrect Message; Material Protrusion/Extrusion
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 256 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. CUSTOMER STATES INSULIN CONTINUES TO DRIP AFTER MOTOR STOPS DURING THE MANUAL PRIME PROCESS. CUSTOMER STATES THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATES THE REWIND MESSAGE OCCURRED AFTER AN ALARM/ALERT. CUSTOMER STATES THEY ARE STUCK IN REWIND COMPLETE/BOLUS DELIVERY LOOP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 6876065 ↗
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, ClassifiedParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- Z-1749-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)
- Z-1256-2025 · Jan 31, 2025 · Open, ClassifiedParadigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Z-2442-2015 · Jul 22, 2015 · TerminatedGuardian 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 · TerminatedMedtronic 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 · TerminatedMedtronic 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
Other Sensor, glucose, invasive devices
- Dexcom G4 Platinum Sensor 9500-27Dexcom, Inc. · Sensor, Glucose, Invasive2 recalls2 deaths99,426 reports
- Dexcom G5 Transmitter Kit STT-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 death58,932 reports
- Dexcom G5 Mobile IOS App SW10611Dexcom, Inc. · Sensor, Glucose, Invasive54,544 reports
- Dexcom G5 Transmitter 9438-06Dexcom, Inc. · Sensor, Glucose, Invasive15,360 reports
- Dexcom G5 Mobile Receiver MT22719Dexcom, Inc. · Sensor, Glucose, Invasive1 death12,594 reports
- Dexcom G4 SBT Transmitter 9438-05Dexcom, Inc. · Sensor, Glucose, Invasive1 death9,041 reports
- Dexcom G5 Mobile Receiver MT22719-BLUDexcom, Inc. · Sensor, Glucose, Invasive7,685 reports
- Dexcom G5 Mobile Receiver Kit STK-GF-001Dexcom, Inc. · Sensor, Glucose, Invasive1 recall6,345 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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