Paradigm® REAL-Time Revel™ MMT-723RNAL (UDI 00643169476585)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00643169476585), received between Jun 13, 2017 and Jul 27, 2020 — classified as 1 death, 18 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 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 DEVICE WAS NOT BUMPED OR DROPPED PRIOR TO THE ALARM AND 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 10325675 ↗
• MalfunctionJul 24, 2020No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP WAS NOT DAMAGED. THE INSULIN PUMP HAD PARTIAL DISPLAY. 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 10318676 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HYPERGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF OVER 600 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS TREATED WITH BOLUS AND MANUAL INJECTION. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS TIRED, ITCHING, DEHYDRATION AND DRY MOUTH. CUSTOMER REPORTED THEY HAD NOT CONTACTED THEIR HEALTHCARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT INSULIN PUMP DID NOT ALLEGE UNDER DELIVERY. CUSTOMER STATED THAT INFUSION SET HAD BENT CANNULA. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Fatigue; Hyperglycemia; Itching Sensation; Polydipsia; Sjogren's Syndrome

  MAUDE report 10069421 ↗
• InjuryMay 19, 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 EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL WAS 600 MG/DL AND 500 MG/DL. CUSTOMER STATED THAT INSULIN PUMP NOT WORKING. CUSTOMER WAS TREATED WITH MANUAL INJECTION AND INSULIN PUMP. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTED THAT THE CANNULA WAS BENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10068477 ↗
• MalfunctionFeb 18, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ACT AND ESC BUTTONS UNRESPONSIVE. CUSTOMER WAS TOOK BATTERY OUT OF THE INSULIN PUMP TO SEE IF THAT WOULD WORK AND INSULIN PUMP HAD BATTERY OUT OF LIMIT ALERT. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9719536 ↗
• DeathDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL EMERGENCY ROOM HALLWAY. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2019 DUE TO LOW BLOOD GLUCOSE THAT CAUSED A FALL. THE CAUSE OF DEATH WAS A BRAIN BLEED DUE TO THE FALL. THE CALLER STATED THAT THE CUSTOMER HAD NO OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH, BUT THE CUSTOMER COULD NOT GET THEIR BLOOD GLUCOSE TO GO UP. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS USING A COMPETITOR'S SENSOR SYSTEM. THE CUSTOMER FELL OUT OF BED DUE TO A LOW AND RECEIVED EMERGENCY MEDICAL ASSISTANCE. THE CUSTOMER WAS GIVEN GLUCOSE BY THE PARAMEDICS TO TREAT THE LOW. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death; Hypoglycemia

  MAUDE report 9434632 ↗
• MalfunctionDec 3, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S BUTTONS WERE STICKING AND NON-RESPONSIVE. THE CUSTOMER BLOOD GLUCOSE LEVEL DURING THE EVENT WAS 123 MG/DL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405335 ↗
• MalfunctionNov 19, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS ARE HARDER TO PRESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT INSULIN PUMP REJECTED NEW BATTERIES, SLOWER DURING REWOUND AND HAD HAIRLINE FRACTURES OR CRACKS IN THE CASING OF INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9340218 ↗
• MalfunctionNov 6, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS WERE STICKING AND NON RESPONSIVE. BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT 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 9283931 ↗
• MalfunctionNov 6, 2019Failure to Cycle; Battery Problem; Failure to Cycle; Battery Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN HAD SQUIRTED OUT DURING PRIMING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT BATTERIES WHERE GOING THROUGH MORE OFTEN. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9283774 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 48 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED FOOD TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FEELING GRUMPY. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER WAS WAKING UP AND EATING THE SAME THING WITHIN THE SAME TIME FRAMES AND THEIR BLOOD GLUCOSE COULD BE 48 MG/DL OR 300 MG/DL. THE CUSTOMER BELIEVES THEIR PUMP WAS OVER DELIVERING INSULIN DUE TO FLUCTUATING BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP, RESERVOIR, AND INFUSION SET WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9279988 ↗
• MalfunctionOct 29, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS WERE HARDER TO PRESS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP HAD SCRATCHES ON SCREEN AND BACKLIGHT WAS LITTLE DARKER, MOTOR MAKES WHIRRING NOISE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9248585 ↗
• MalfunctionOct 29, 2019Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON THE DISPLAY AND RAINBOW EFFECT AND HARD TO READ. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP REWIND SLOWER THAN IT HAD IN THE PAST. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9248451 ↗
• MalfunctionOct 25, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM DURING BASAL WHEN THE RESERVOIR WAS ALMOST OUT. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THE INSULIN PUMP ALARM HISTORY CONTAINS MORE THAN ONE MOTOR ERROR ALARM WITHIN THE LAST 30 DAYS. 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 9236783 ↗
• MalfunctionOct 24, 2019Premature Discharge of Battery; Premature Discharge of Battery

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 193 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR ALARM AND ABLE TO COMPLETE REWIND. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD ANOTHER UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9236591 ↗
• MalfunctionOct 23, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR ALARM PAST FEW MONTHS WHEN PUMP RUNS OUT OF INSULIN. THE BLOOD GLUCOSE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9222754 ↗
• MalfunctionOct 15, 2019Failure to Cycle; Patient Device Interaction Problem; Failure to Cycle; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 125 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD CRACK ON THE UPPER RIGHT HAND CORNER OF THE SCREEN. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. TROUBLESHOOTING WAS PERFORMED. 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 9191954 ↗
• InjuryOct 5, 2019No Display/Image; No Apparent Adverse Event; No Display/Image; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP WAS NOT CAME ON ANYMORE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THE CUSTOMER DID NOT SEE ANY PHYSICAL DAMAGE ON INSULIN PUMP. THE INSULIN PUMP WAS NOT BUMPED, DROPPED OR EXPOSED TO MOISTURE. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DISPLAY DID NOT RETURNED BACK. 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 9159815 ↗
• MalfunctionSep 13, 2019Material Integrity Problem; Patient Device Interaction Problem; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD CRACKED NEAR BATTERY COMPARTMENT AND BATTERY CAP. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF 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 AS PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9020354 ↗
• MalfunctionSep 6, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP KEYPAD BUTTONS REQUIRE MULTIPLE PRESSES TO RESPOND. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER STATED READING THE SCREEN WAS DIFFICULT FROM SCRATCHES AND WEAR. CUSTOMER ALSO STATED THAT BATTERY CAP WAS WARPING AND CHIPS. CUSTOMER STATED INSULIN PUMP HAD TO REWIND MORE THAN ONCE EVERY 2 WEEKS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8970289 ↗
• InjuryJul 9, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 409 MG/DL. CUSTOMER ALSO REPORTED THAT INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. 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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8770340 ↗
• MalfunctionJul 3, 2019Intermittent Communication Failure; Intermittent Communication Failure

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR CURRENT ERROR DETECTED. CUSTOMER'S BLOOD GLUCOSE LEVEL 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 8756884 ↗
• MalfunctionJun 24, 2019No Display/Image; No Display/Image

  CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATES THE CONTACTS ON THE BATTERY CAP ARE NEITHER MISSING NOR DAMAGED, BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED AND THE SPRING WAS NEITHER DAMAGED NOR CORRODED. TROUBLE SHOOTING WAS PERFORMED FOR BLANK DISPLAY. CUSTOMER WAS ADVISED TO CLEAN BATTERY CAP CONTACTS WITH A DRY COTTON SWAB, IF NO ISO PROPYL ALCOHOL IS AVAILABLE TO USE AN ALCOHOL WIPE OR DRY COTTON SWAB. ADVISED TO ALLOW AT LEAST ONE MINUTE FOR THE BATTERY CONTACTS TO DRY AND TO INSERT NEW AA BATTERY. DISPLAY DID NOT RETURN AFTER PUMP RESTART. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726814 ↗
• MalfunctionJun 17, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP UP AND DOWN BUTTONS HARD TO PRESS SOMETIMES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES BACK LIGHT WAS FOGGY LOOKING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703196 ↗
• MalfunctionJun 14, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; 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 352 MG/DL. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS STICKING OUT. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698911 ↗

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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-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