Paradigm® REAL-Time Revel™ MMT-723NAL (UDI 00643169077713)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-723NAL PRDGM INS V2.4 CL EN PR · Class 3
All models of Paradigm REAL-Time Revel (180)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic MiniMed Paradigm REAL-Time Revel insulin pump has 110 adverse event reports, with no deaths and 25 injuries. Reports most often describe pump alarms and error messages that appear unexpectedly, and mechanical problems such as cracked battery caps or housings. Some reports mention high blood sugar and a few mention low blood sugar. 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
- 110
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00643169077713), received between Jun 5, 2017 and Sep 5, 2023 — classified as 25 injuries, 85 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (29 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
- Device Displays Incorrect Message29
- Patient Device Interaction Problem19
- Mechanical Problem18
- Device Difficult to Program or Calibrate14
- Failure to Cycle14
- Power Problem10
- Device Operates Differently Than Expected9
- Material Protrusion/Extrusion8
Patient problems
- No Consequences Or Impact To Patient77
- Hyperglycemia28
- Hypoglycemia5
- No Clinical Signs, Symptoms or Conditions2
- Lethargy1
- Pain1
Recent adverse event reports
The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2023Material Integrity Problem; Material Integrity Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BATTERY CAP WERE DAMAGED. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17680833 ↗MalfunctionAug 5, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR AND BUTTON ERROR ALARM. CUSTOMER STATED THAT RESERVOIR AREA AND BATTERY CAP WAS CRACK. CUSTOMER STATED THAT INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM AND REWIND WAS SLOWER AND GRIND. 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 10366872 ↗MalfunctionMay 29, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER STATED THAT THEY WERE UNABLE TO DESCRIBE THE POSSIBLE DAMAGE TO THE DRIVE SUPPORT CAP. CUSTOMER STATED THAT INSULIN PUMP HAD NOT BEEN EXPOSED TO HIGH MAGNETIC FIELD. 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 10100597 ↗MalfunctionMay 28, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE HARD TO PRESS. ALSO REPORTED CRACK ON THE FRONT OF THE INSULIN PUMP AND ALSO WAS LOUDER TO REWIND. 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 10095661 ↗MalfunctionMay 5, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY AND MOTOR ERROR ALARM. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS ABLE TO COMPLETE THE REWIND. THE INSULIN PUMP HAD REOCCURRING MOTOR ERRORS. 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 10027286 ↗MalfunctionApr 16, 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 A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. THE DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND THE DRIVE SUPPORT CAP APPEARS LOOSE. 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 9970277 ↗MalfunctionApr 9, 2020Display or Visual Feedback Problem; Obstruction of Flow; Display or Visual Feedback Problem; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED ALARM IT DID NOT DELIVERED AND TOUCH SCREEN DID NOT ALWAYS RESPOND. 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 9942720 ↗MalfunctionMar 20, 2020Mechanical Problem; Power Problem; Mechanical Problem; Power Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT INSULIN PUMP WOULD BE RANDOMLY SHUT OFF AND AFTER INSERTING A NEW BATTERY THE INSULIN PUMP WILL BE ON. 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 9858923 ↗MalfunctionFeb 24, 2020Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND MOTOR POSITION ENCODER ERROR. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9743411 ↗MalfunctionFeb 13, 2020Power Problem; Power Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP NO LONGER POWERS ON. THE CUSTOMER STATED THEY HAD BEEN OFF INSULIN PUMP FOR FOUR YEARS. 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 9705317 ↗MalfunctionFeb 3, 2020No Display/Image; Material Integrity Problem; Patient Device Interaction Problem; No Display/Image; Material Integrity Problem; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DOES NOT WORK. THE CUSTOMER TRIED TO PUT A NEW BATTERY IN AND THEY WERE GETTING A BLANK SCREEN. THE CUSTOMER WAS NOT CALLING BACK AFTER RECEIVING A NEW BATTERY CAP. THE CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP ARE NEITHER MISSING NOR DAMAGED. THE CUSTOMER REPORTED DAMAGE ON THE INSULIN PUMP AT THE BATTERY CAP AND THAT BATTERY COMPARTMENT LIP. THE DISPLAY DID NOT RETURN AFTER THE INSULIN PUMP RESTART. 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 9658615 ↗MalfunctionJan 11, 2020Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Battery Problem; Patient Device Interaction Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SQUIRT INSULIN, INSULIN PUMP HAD CRACK AND WAS GETTING BIGGER BY BATTERY ON THE SIDE TOWARDS BOTTOM, BATTERY CHANGE OR REJECTED OR DRAINED BATTERY WHEN NEW WITHIN SIX DAYS AND MOTOR SOUNDS OR GRINDING A LITTLE LOUDER. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER DECLINED TO REPORT TO 24 HOURS HELPLINE TECHNICAL SUPPORT DEPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9579009 ↗MalfunctionDec 30, 2019Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP TWICE ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED INSULIN CONTINUES TO DRIP AFTER MOTOR STOPS DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE 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 9529289 ↗MalfunctionDec 17, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT WHEN THE INSULIN PUMP WAS DELIVERING A BOLUS HE COULD HEAR THE MOTOR RUNNING AND A CLICKING SOUND AS THE INSULIN WAS BEING DELIVERED. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND RESOLVED BY CHANGING COMPLETE SET. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR,UNOMED-SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9478932 ↗MalfunctionDec 13, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP RING WAS MISSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 312 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER REPORTED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. 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 AS PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9466092 ↗MalfunctionDec 10, 2019Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD ISSUES WITH ERROR MESSAGES DURING BATTERY, RESERVOIR AND TUBING CHANGE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED LARGE CRACK ON THE INSULIN PUMP. CUSTOMER DECLINED TRANSFER TO HELPLINE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9443163 ↗MalfunctionOct 31, 2019Failure of Device to Self-Test; Wireless Communication Problem; Failure of Device to Self-Test; Wireless Communication Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RF PIC FAILED SELF-TEST. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 380 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. SELF TEST WAS FAILED. THE CUSTOMER WAS ADVISED TO REPLACE AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9259228 ↗MalfunctionOct 31, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STUCK BUTTON. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE TIME WAS MOVING. ADVISED CUSTOMER TO MONITOR THE INSULIN PUMP FOR 3 MINUTES TO VERIFY TIME CLOCK WORKS PROPERLY AND FROZEN DISPLAY OR ALARMS ID NOT RECUR. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9258694 ↗MalfunctionOct 25, 2019Date/Time-Related Software Problem; Patient Device Interaction Problem; Date/Time-Related Software Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CLOCK TIME OF THE INSULIN PUMP WAS BEHIND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED CRACK ON SIDE OF THE INSULIN PUMP. CUSTOMER DECLINED TO REPORT TO MEDTRONIC 24 HOUR TECHNICAL SUPPORT DEPARTMENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9237038 ↗MalfunctionSep 30, 2019Premature Discharge of Battery; Premature Discharge of Battery
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. THE UNEXPECTED RESTART ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER WAS ADVISED TO REMOVE THE CURRENT BATTERY FROM THE INSULIN PUMP AND INSERT A NEW BATTERY AND INSULIN PUMP AGAIN ALARMED UNEXPECTED RESTART. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9133410 ↗MalfunctionSep 30, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT WHEN THEY WENT TO CHANGE THE INSULIN PUMP IT SQUIRTED INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 76 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER HAD ISSUES ON THE INSULIN PUMP GETTING PASSED THE PRIME SEQUENCE OF THE INSULIN PUMP. THEY TRIED CHANGING BATTERIES AND PUTTING IN A NEW SET AND RESERVOIR AND STATED THAT THE BEHAVIOR WAS THE SAME. THE CUSTOMER STATED THAT USUALLY IT¿S A DROP BUT THIS TIME IT WAS SQUIRTING A LOT OF INSULIN AND WHEN THEY HIT ACT IT WILL FLOW FOUNTAIN OF INSULIN AND WHEN THEY PRESS ESCAPE IT WILL ASK AGAIN IF THEY WERE DISCONNECTED. THE CUSTOMER ALSO REPORTED A COUPLE CRACKS ON THE INSULIN PUMP THAT HAVE BEEN THERE FOR SEVERAL YEARS. IT WAS REPORTED THAT THE RESERVOIR LIP RING WAS DAMAGED BUT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. 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 9132920 ↗MalfunctionSep 17, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS OF INSULIN PUMP HAD TO PRESS MORE THAN ONCE TO GET RESPONSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM AND CRACK NEXT TO SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9077727 ↗MalfunctionSep 4, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Insufficient Device Problem Information; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE LESS RESPONSIVE, HARDER TO PRESS AND SOMETIMES HAD TO BE PRESSED TWICE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED MOTOR ERRORS, CHANGING BATTERIES MORE OFTEN, REWIND MORE THAN ONCE, A OR E CODES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8958863 ↗MalfunctionAug 29, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP MOTOR POSITION ENCODER ERROR AND HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO REPLACE AND 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 8944087 ↗MalfunctionAug 29, 2019Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD MOTOR ERROR AND SHUT DOWN RECENTLY BUT CAME BACK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN THAT GET IN WAY OF VIEWING IT AND SCREEN WAS CLOUDY AND REJECTED NEW BATTERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8943585 ↗
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-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1592-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Z-1588-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Z-1594-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Z-1593-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Z-1590-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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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