Paradigm® REAL-Time Revel™ MMT-523NAB (UDI 00643169077645)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-523NAB PRDGM INS V2.4 BL 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 is a Medtronic MiniMed Paradigm Revel insulin pump, an implanted-in-body glucose sensor system that delivers insulin continuously. The 27 reports mostly describe the pump breaking or stopping working — buttons that stop responding, cracked battery compartment threading, a reservoir that will not lock in place, and one unit held together with tape — along with display error messages and high or low blood sugar readings. Reports mention 1 death and 10 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
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169077645), received between Jun 2, 2017 and Mar 30, 2020 — classified as 1 death, 10 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 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 Message6
- Adverse Event Without Identified Device or Use Problem3
- Break3
- Device Difficult to Program or Calibrate3
- Patient Device Interaction Problem3
- Device Inoperable2
- Loose or Intermittent Connection2
- Component Missing1
Patient problems
- No Consequences Or Impact To Patient12
- Hyperglycemia11
- Hypoglycemia2
- Death1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
INFORMATION INDICATED BY MEDTRONIC THAT THE INSULIN PUMP WAS BEING HELD TOGETHER BY TAPE. 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 9901434 ↗MalfunctionNov 11, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE FAILED TO RESPOND. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9304080 ↗MalfunctionSep 10, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP BUTTONS WERE NOT RESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8979817 ↗MalfunctionJul 11, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS NOT ABLE TO LOCKED IN PLACE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 125 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THE THREADING AROUND BATTERY CHAMBER WAS CRACKED AND THEY COULD NOT GET THE BATTERY TO STAY IN. 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 8779300 ↗MalfunctionFeb 28, 2019Premature Discharge of Battery; Premature Discharge of Battery
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 155 MG/DL. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8380694 ↗MalfunctionJan 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BATTER COMPARTMENT THREADING IS ALL BROKEN UP SO THE BATTERY CAP CAN NOT SCREW DOWN INTO IT . CUSTOMER WENT TO PUT THE BATTERY CAP ON THE INSULIN PUMP AND THE LIP JUST BROKE AWAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. 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 8288061 ↗InjuryAug 28, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STUCK BUTTON AND THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT MENTION ANY FORM OF TREATMENT FOR THEIR BLOOD GLUCOSE LEVELS. 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: Hyperglycemia
MAUDE report 7824136 ↗DeathAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014. THE CAUSE OF DEATH WAS RENAL FAILURE, DIABETES, AND CARDIAC ISSUES. THE CALLER STATED THAT THE CUSTOMER HAD RENAL ISSUES, DIABETES, BROKEN HIP, FOOT ISSUES, AND A LEG AMPUTATION 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 CUSTOMER FELL IN MARCH AND PASSED IN (B)(6) OF THAT YEAR. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: Death
MAUDE report 7792374 ↗InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 386 MG/DL. THE OTHER RELEVANT BLOOD GLUCOSE WAS 300 MG/DL AND 185 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7703694 ↗InjuryJul 4, 2018Failure To Adhere Or Bond
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A BLOOD GLUCOSE LEVEL OF 450 MG/DL DUE TO AN INFUSION SET NOT STICKING. HIGH BLOOD GLUCOSE TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WAS NOT REPLACED OR RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7662590 ↗MalfunctionApr 3, 2018Device Inoperable; Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR AND UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE WAS 199 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND THE BUTTONS WERE UNRESPONSIVE. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER REPORTED THAT THE INSULIN PUMP WOULD ALARM EACH TIME SHE CHANGES OUT THE BATTERY. 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 7392944 ↗MalfunctionFeb 23, 2018Improper Flow or Infusion
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME LOOP AND INSULIN SQUIRTED OUT DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE WAS 84 MG/DL. THE CUSTOMER STATED THAT PUMP DID NOT EXITED THE REWIND COMPLETE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7293312 ↗MalfunctionFeb 12, 2018Break; Torn Material
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT WHEN THE RESERVOIR WAS INSERTED INTO THE INSULIN PUMP THE THREADS WERE TORN AND FALLING APART. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7264549 ↗MalfunctionFeb 2, 2018No Display/Image; Device Displays Incorrect Message
CUSTOMER¿S MOTHER WAS REPORTED VIA PHONE CALL THAT, THE INSULIN PUMP HAD OFF NO POWER ALARM AND HAD BLANK DISPLAY SCREEN ALSO. THE BLOOD GLUCOSE WAS 154 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT, THEY DID RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. CUSTOMER CHANGED BATTERY LAST WEEK AND 10-15 MINUTES AGO THE ALARM SHOWED POWERING OFF. NEW BATTERY RESOLVED THE ISSUE. ASSISTED CUSTOMER WITH BLANK DISPLAY TROUBLESHOOTING AND TROUBLESHOOTING DETERMINED THAT, THE INSULIN PUMP SHOULD BE REPLACED. THE CUSTOMER ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7236388 ↗InjuryJan 24, 2018Component Missing; Malposition of Device
THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD HIGH BLOOD GLUCOSE OF 538 MG/DL AND CUSTOMER TREATED IT WITH A MANUAL SHOT. CUSTOMER ALSO REPORTED THAT, THE WHOLE TOP OF THE RESERVOIR COMPARTMENT IS MISSING AND RESERVOIR WAS NOT LOCKING IN PLACE. CUSTOMER DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE. TROUBLESHOOTING DETERMINED THAT, THE INSULIN PUMP SHOULD BE REPLACED. THE CUSTOMER ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7216366 ↗MalfunctionJan 12, 2018Break; Device Slipped
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COSMETIC DAMAGE AND THE RESERVOIR IS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROFESSIONAL¿S INSTRUCTION. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT PUMP WILL BE SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7187095 ↗MalfunctionJan 4, 2018Break; Device Displays Incorrect Message; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD AN UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 349 MG/DL. THE CUSTOMER STATED THAT THEY HAD DAMAGE TO THEIR PUMP AND WAS ALSO GETTING AN UNEXPECTED RESTART ALARM. CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE TROUBLESHOOTING WAS PERFORMED AND WAS ADVISED TO REMOVE THE CURRENT BATTERY FROM THE PUMP AND INSERT A NEW BATTERY (PER IFU GUIDELINES) AND PUMP ALARMED UNEXPECTED RESTART. THE CUSTOMER ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER ADVISED TO MONITOR THE PUMP AND THAT PATIENT MAY CONTINUE TO WEAR THE PUMP UNTIL REPLACEMENT ARRIVES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7166592 ↗MalfunctionDec 1, 2017Device Inoperable; Material Deformation
THE CUSTOMER REPORTED VIA PHONE CALL THAT HER DAUGHTER'S INSULIN PUMP HAD A KEYPAD ANOMALY. THE BUTTONS WERE HARD TO PRESS. SHE ALSO STATED THAT THE RESERVOIR IS NOT STAYING IN PLACE DUE TO PHYSICAL DAMAGE TO THE RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS AROUND 300 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7077165 ↗InjuryNov 27, 2017Insufficient Device Problem Information
CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE VALUE AT TIME OF INCIDENT WAS 315 MG/DL AND CURRENT BLOOD GLUCOSE VALUE WAS 598 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA, FREQUENT URINATING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS NOT ABLE TO COMPLETE THE TROUBLESHOOT. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7062182 ↗MalfunctionNov 7, 2017Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PUMP ALARMED NEW SOFTWARE RELEASE DETECTED AND FAILURE OF FLASH MEMORY ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE ALARM DID NOT OCCUR DURING THE REWIND AND PRIME SEQUENCE. THE CUSTOMER RECEIVED A SECOND NEW SOFTWARE RELEASE DETECTED AFTER CLEARING THE ALARM. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7006838 ↗InjuryOct 12, 2017Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT ON (B)(6) 2017 AT 6 PM THE PARAMEDICS WAS DISPATCHED BECAUSE THE CUSTOMER HAD A LOW BLOOD GLUCOSE OF 24 MG/DL. THE CUSTOMER HAD PASSED OUT. THE CUSTOMER WAS TREATED WITH INSULIN INTRAVENOUS THERAPY. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE INCIDENT. THEY DECLINED TROUBLESHOOTING FOR THE LOW BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 6946011 ↗MalfunctionAug 8, 2017Loose or Intermittent Connection
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE SUPPORT CAP WAS LOOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6775266 ↗InjuryJul 31, 2017Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT HE EXPERIENCED HIGH BLOOD GLUCOSE AND A NO DELIVERY ALARM. HE SAID THAT HE HAD A BLOOD GLUCOSE OF 271 MG/DL AT 9:30 PM THE NIGHT PRIOR AND 490 MG/DL THIS MORNING. HE SAID THAT AFTER HE RECEIVED 1 UNIT, HE GOT A NO DELIVERY ALARM. HE ALSO HAD A BLOOD GLUCOSE OF 445 MG/DL, 400 MG/DL, 326 MG/DL, 248 MG/DL AND 199 MG/DL. DURING HIGH BLOOD GLUCOSE TROUBLESHOOTING, THE CUSTOMER SAID THAT THEIR BLOOD GLUCOSE WAS 326 MG/DL AT THE TIME OF THE EVENT AND THAT THEIR CURRENT BLOOD GLUCOSE WAS 400 MG/DL. THE CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE WITH THEIR PUMP. HE SAID THAT HIS DRIVE SUPPORT CAP APPEARED NORMAL. HE SAID THAT HIS DOCTOR RECENTLY CHANGED HIS SETTINGS BECAUSE OF HIS HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ASSISTED WITH PERFORMING THE HIGH-PRESSURE TEST AND THE TEST PASSED. HE WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER HIS DOCTOR¿S INSTRUCTIONS. THE INSULIN PUMP IS BEING RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6755758 ↗InjuryJul 28, 2017Device Operates Differently Than Expected
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS OVER 600 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT NUMBERS KEPT ON SCROLLING ON THE INSULIN PUMP WHILE TRYING TO PROGRAM A BOLUS. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND UNABLE TO CONFIRM IF THE TIME IS ADVANCING DUE TO INSULIN PUMP WAS NOT WITH THE CUSTOMER. CUSTOMER ALSO REPORTED TO HAVE EXPERIENCED A HIGH BLOOD GLUCOSE OF OVER 600 MG/DL DUE TO KEYPAD ANOMALY AND TREATED WITH MANUAL INJECTION. NO HIGH BLOOD GLUCOSE TROUBLESHOOTING WAS PERFORMED. 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: Hyperglycemia
MAUDE report 6752613 ↗InjuryJun 21, 2017Fluid/Blood Leak; Failure to Align
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 408 MG/DL. CUSTOMER CHANGED THE ENTIRE SET AND BLOOD GLUCOSE WAS 419 MG/DL. THE CUSTOMER TREATED THE HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 293 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED THE TRANSFER GUARD NEEDLE WAS CROOKED AND INSULIN WAS COMING OUT. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS. CUSTOMER WAS ADVISED THE INFUSION SET AND RESERVOIR WILL BE REPLACED. THE CUSTOMER WILL RETURN THE RESERVOIR AND INFUSION SET FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6656843 ↗
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, ClassifiedParadigm REAL-Time Insulin Pump (MMT-522, MMT-722)
- Z-1750-2026 · Feb 13, 2026 · Open, ClassifiedParadigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- 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-1589-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Z-1587-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-522
- 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-1591-2020 · Jun 27, 2019 · Open, ClassifiedMedtronic MiniMed Paradigm Insulin pump, model number MMT-523
- 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-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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