Paradigm Real-Time Revel Insulin Pump With Enlite Sensor System MMT-723RNASRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00643169693937), received between Aug 27, 2018 and May 8, 2020 — classified as 23 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 reports).

14 other recalls cover devices cleared under the same FDA submission (P150019, 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER REPORTED EVENT WAS RESOLVED BY CHANGING COMPLETE SET. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10037514 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL EXPERIENCING HIGH BLOOD GLUCOSE READING OF 500 MG/DL. THE CUSTOMER REPORTED TREATING WITH THE INSULIN PUMP AND THE BLOOD GLUCOSE READING HAS COME DOWN. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9910003 ↗
• MalfunctionJan 31, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND THE INSULIN PUMP. CUSTOMER STATED THE INSULIN PUMP ALARM OCCURRED AFTER BATTERY CHANGED. 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 9650763 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 440 MG/DL AND 250 MG/DL AT THE TIME OF INCIDENT AND OTHER BLOOD GLUCOSE WAS 296 MG/DL. THE CUSTOMER WAS TREATED WITH BOLUS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9600111 ↗
• MalfunctionJan 14, 2020No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 138 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CUSTOMER REPORTS DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATED THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. ADVISED CUSTOMER TO REMOVE THE BATTERY AND CUSTOMER STATED THE INSERT BATTERY ALARM DID NOT DISPLAY ON THE INSULIN PUMP SCREEN. CUSTOMER STATED THE CONTACT ON THE BATTERY CAP WAS NOT MISSING OR DAMAGE OR CORRODED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE DISPLAY DID NOT RETURN AFTER INSULIN 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 INSULIN 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 9584982 ↗
• InjuryDec 18, 2019No Display/Image; Insufficient Device Problem Information; No Display/Image; Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP WAS NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AND 500 MG/DL. INSULIN PUMP HAD ABSENCE OF NO DELIVERY ALARM. CUSTOMER WAS TAKING LARGE BOLUS AND BLOOD GLUCOSE WAS NOT GETTING DOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9486228 ↗
• InjuryDec 13, 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 EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER HIGH BLOOD GLUCOSE LEVEL WAS 550 MG/DL. CUSTOMER REPORTED THAT THEY JUST CHANGED SET AND IT WAS LEAKING AT TOP WHERE THE NEEDLE GOES THROUGH. CUSTOMER STATED LOCATION OF THE LEAK WAS QUICK RELEASE. CUSTOMER STATED THE QUICK RELEASE WAS TIGHTLY CONNECTED. CUSTOMER STATED INSULIN PUMP WAS NOT DROPPED WITH SET IN PLACE. THE INFUSION SET WILL BE RETURNED AND INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9466239 ↗
• MalfunctionOct 28, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT RESERVOIR LIP RING OF INSULIN PUMP HAD CRACK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 137 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT RESERVOIR DID NOT LOCK IN PLACE WHILE INSERTED. 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 9247307 ↗
• InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER'S SPOUSE REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE OF 40 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 57 MG/DL AND CUSTOMER WAS TREATED BY EATING HOTDOG, GLUCOSE TABLETS & GRAPES. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT INSULIN HAS BEEN SUSPENDED FOR 2 HOURS DUE TO LOW BLOOD GLUCOSE EVENTS. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9241605 ↗
• MalfunctionOct 23, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THEY GOT A REPLACEMENT CAP AND AFTER THAT, THEY WERE HAVING ISSUES WITH MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 9224019 ↗
• MalfunctionOct 9, 2019Priming Problem; Priming Problem

  THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT HIS INSULIN PUMP WAS STUCK ON FILL TUBING AND UNABLE TO EXIT THE PREPARING TO PRIME LOOP. BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THEY DID NOT RECEIVE 2ND 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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171669 ↗
• MalfunctionSep 27, 2019Mechanical Problem; Power Problem; Mechanical Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BATTERY OUT LIMIT ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS NOT ABLE TO COMPLETE REWIND. 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 9127474 ↗
• InjurySep 24, 2019Adverse 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 EXPERIENCED HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 588 MG/DL AT THE TIME OF INCIDENT. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT IN THE MORNING THE BLOOD GLUCOSE WAS 118 MG/DL, TOOK MANUAL INJECTION AS IT WAS HIGH LAST NIGHT. CUSTOMER THEN STATED THAT THE ANKLES WERE SWOLLEN AND WHEN TESTED THE BLOOD GLUCOSE WAS 317 MG/DL. CUSTOMER THEN TESTED THE BLOOD GLUCOSE 11 TIMES IN THE MORNING AND THE BLOOD GLUCOSE WAS 245 MG/DL AND 283 MG/DL, LATER TOOK A SHOT AND THE BLOOD GLUCOSE WAS 118 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9110007 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT HIS WIFE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTS THEY FEEL OKAY TO TROUBLE SHOOT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8831063 ↗
• InjuryJun 25, 2019Priming Problem; Priming Problem

  THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT HER HUSBAND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD REWIND ANOMALY AND THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP AND TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED THEY DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8729921 ↗
• MalfunctionJun 13, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP UNDER DELIVERING. THE CUSTOMER'S BLOOD GLUCOSE WAS 277, 377 MG/DL. THE CUSTOMER TREATED WITH THE BOLUS WITH INSULIN PUMP. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES ALLEGE PUMP WAS UNDER DELIVERING BECAUSE BLOOD GLUCOSE WAS KEPT GOING UP. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS

  Patient problems: Hyperglycemia

  MAUDE report 8694737 ↗
• InjuryJun 6, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL TO 400 MG/DL. THE CUSTOMER WAS TREATED WITH BLOUSED. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER STATED THAT THEY HAD TRIED ALL REMEDIES. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. 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 8673831 ↗
• MalfunctionMay 16, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE UP AND DOWN ARROW BUTTONS OF THE INSULIN PUMP WERE NOT WORKING. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 111 MG/DL AT THE TIME OF THE INCIDENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8614915 ↗
• InjuryMay 3, 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 THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 29 MG/DL. THE CUSTOMER CURRENT BLOOD GLUCOSE WAS 212 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8577558 ↗
• InjuryMay 2, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT CUSTOMER¿S EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 525 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER ALSO REPORTED THAT THEY GOT NO DELIVERY ALARM ON THE INSULIN PUMP. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NOT CALLING BACK TO PERFORM AN HIGH PRESSURE TEST. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. CUSTOMER ALSO STATED THAT THE DRIVE SUPPORT CAP WAS APPEARS TO BE NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8572300 ↗
• MalfunctionMay 1, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO THE BREAST CANCER AND HAD A MASTECTOMY NOT BECAUSE OF DIABETES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8568262 ↗
• MalfunctionApr 26, 2019Premature Discharge of Battery; Power Problem; Premature Discharge of Battery; Power Problem

  THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER ABLE TO COMPLETE REWIND. THE TROUBLESHOOTING WAS PERFORMED FOR THE INSULIN PUMP ERROR ALARM. THE CUSTOMER WAS CALLING BACK AFTER COMPLETING PUMP ERROR ALARM TROUBLESHOOTING AND RECEIVING ANOTHER PUMP ERROR ALARM AFTER A BATTERY CHANGE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED AND DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8553796 ↗
• InjuryMar 28, 2019Adverse 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 EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS AND TREATMENT OF HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8458936 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER BLOOD GLUCOSE LEVEL WAS 490 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 323 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN PUMP. CUSTOMER NOT ALLEGING THAT THE INSULIN PUMP WAS UNDER DELIVERING AND DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8407012 ↗
• InjuryMar 4, 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 THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 444 MG/DL. THE CUSTOMER'S OTHER BLOOD GLUCOSE WAS 410 MG/DL, 314 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8385922 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, P980022. One submission often covers many models, so check the product and lot details in each record.

• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• 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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-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