Paradigm REAL-Time RevelRecalls & reported problems across all models
Medtronic Minimed, Inc. · 180 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Paradigm REAL-Time Revel model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 49,838
- Deaths reported
- 328
- Injuries reported
- 18,604
- Recalls
- 2
We found 180 models of Paradigm REAL-Time Revel by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). Together they are named in 49,838 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2014 and Jun 8, 2026 — classified as 328 deaths, 18,604 injuries, 30,906 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (7,339 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Paradigm REAL-Time Revel recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 13, 2026Open, Classified
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Z-1752-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Feb 13, 2026Open, Classified
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Z-1750-2026 · Root cause: Device Design · names 9 of these models · Recall details · FDA record ↗
Most reported Paradigm REAL-Time Revel problems
Device problems
- Adverse Event Without Identified Device or Use Problem7,537
- Device Difficult to Program or Calibrate7,339
- Mechanical Problem6,546
- Patient Device Interaction Problem6,211
- Device Displays Incorrect Message6,134
- Obstruction of Flow4,717
- No Apparent Adverse Event4,612
- No Display/Image4,252
Patient problems
- No Consequences Or Impact To Patient27,530
- Hyperglycemia18,390
- Hypoglycemia4,381
- Elevated Ketones/ Diabetic Ketoacidosis907
- Death384
- No Known Impact Or Consequence To Patient324
- Nausea264
- Vomiting234
Paradigm REAL-Time Revel models
180 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Paradigm® REAL-Time Revel™ MMT-723NASSensor, glucose, invasive15 deaths3,413 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASSensor, glucose, invasive1 recall12 deaths2,995 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASSensor, glucose, invasive1 recall18 deaths2,909 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASSensor, glucose, invasive1 recall23 deaths2,570 reports
- Paradigm® REAL-Time Revel™ MMT-723RNASSensor, glucose, invasive18 deaths1,970 reports
- Paradigm® REAL-Time Revel™ MMT-723NAPSensor, glucose, invasive7 deaths1,564 reports
- Paradigm® REAL-Time Revel™ MMT-723NALSensor, glucose, invasive9 deaths1,504 reports
- Paradigm® REAL-Time Revel™ MMT-723NABSensor, glucose, invasive8 deaths1,492 reports
- Paradigm® REAL-Time Revel™ MMT-723LNALSensor, glucose, invasive9 deaths1,271 reports
- Paradigm® REAL-Time Revel™ MMT-523NASSensor, glucose, invasive9 deaths1,259 reports
- Paradigm® REAL-Time Revel™ MMT-723LNAPSensor, glucose, invasive7 deaths1,256 reports
- Paradigm® REAL-Time Revel™ MMT-723LNABSensor, glucose, invasive10 deaths1,243 reports
- Paradigm® REAL-Time Revel™ MMT-523LNASSensor, glucose, invasive6 deaths1,199 reports
- Paradigm® REAL-Time Revel™ MMT-723LNAHSensor, glucose, invasive4 deaths961 reports
- Paradigm® REAL-Time Revel™ MMT-723NAHSensor, glucose, invasive3 deaths935 reports
- Paradigm® REAL-Time Revel™ MMT-523RNASSensor, glucose, invasive8 deaths897 reports
- Paradigm® REAL-Time Revel™ MMT-723RNABSensor, glucose, invasive2 deaths867 reports
- Paradigm® REAL-Time Revel™ MMT-723NASSensor, glucose, invasive1 recall6 deaths796 reports
- Paradigm® REAL-Time Revel™ MMT-523LNALSensor, glucose, invasive3 deaths841 reports
- Paradigm® REAL-Time Revel™ MMT-723RNALSensor, glucose, invasive4 deaths772 reports
- Paradigm® REAL-Time Revel™ MMT-723RNAPSensor, glucose, invasive6 deaths758 reports
- Paradigm® REAL-Time Revel™ MMT-723NASSensor, glucose, invasive6 deaths706 reports
- Paradigm® REAL-Time Revel™ MMT-723RNASSensor, glucose, invasive19 deaths672 reports
- Paradigm® REAL-Time Revel™ MMT-523NALSensor, glucose, invasive1 death671 reports
- Paradigm® REAL-Time Revel™ MMT-523LNAPSensor, glucose, invasive2 deaths597 reports
- Paradigm® REAL-Time Revel™ MMT-523LNABSensor, glucose, invasive5 deaths592 reports
- Paradigm® REAL-Time Revel™ MMT-523NAPSensor, glucose, invasive553 reports
- Paradigm® REAL-Time Revel™ MMT-523NABSensor, glucose, invasive3 deaths546 reports
- Paradigm® REAL-Time Revel™ MMT-723RNAHSensor, glucose, invasive3 deaths512 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASSensor, glucose, invasive1 recall4 deaths461 reports
- Paradigm® REAL-Time Revel™ MMT-723NASSensor, glucose, invasive1 recall5 deaths453 reports
- Paradigm® REAL-Time Revel™ MMT-723NASSensor, glucose, invasive2 recalls2 deaths376 reports
- Paradigm® REAL-Time Revel™ MMT-523LNAHSensor, glucose, invasive4 deaths443 reports
- Paradigm® REAL-Time Revel™ MMT-723LNALSensor, glucose, invasive4 deaths441 reports
- Paradigm® REAL-Time Revel™ MMT-523RNALSensor, glucose, invasive438 reports
- Paradigm® REAL-Time Revel™ MMT-523NAHSensor, glucose, invasive1 death385 reports
- Paradigm® REAL-Time Revel™ MMT-523RNABSensor, glucose, invasive3 deaths376 reports
- Paradigm® REAL-Time Revel™ MMT-523RNAPSensor, glucose, invasive362 reports
- Paradigm® REAL-Time Revel™ MMT-723NABSensor, glucose, invasive4 deaths328 reports
- Paradigm® REAL-Time Revel™ MMT-723NABSensor, glucose, invasive2 deaths322 reports
- Paradigm® REAL-Time Revel™ MMT-523RNASSensor, glucose, invasive2 deaths309 reports
- Paradigm® REAL-Time Revel™ MMT-523NASSensor, glucose, invasive1 death292 reports
- Paradigm® REAL-Time Revel™ MMT-523LNASSensor, glucose, invasive274 reports
- Paradigm® REAL-Time Revel™ MMT-723NAPSensor, glucose, invasive273 reports
- Paradigm® REAL-Time Revel™ MMT-723NALSensor, glucose, invasive1 death268 reports
- Paradigm® REAL-Time Revel™ MMT-723RNASSensor, glucose, invasive4 deaths258 reports
- Paradigm® REAL-Time Revel™ MMT-723RNABSensor, glucose, invasive5 deaths248 reports
- Paradigm® REAL-Time Revel™ MMT-723LNALSensor, glucose, invasive1 death239 reports
- Paradigm® REAL-Time Revel™ MMT-723NAPSensor, glucose, invasive3 deaths233 reports
- Paradigm® REAL-Time Revel™ MMT-523NASSensor, glucose, invasive2 deaths222 reports
- Paradigm® REAL-Time Revel™ MMT-723NALSensor, glucose, invasive1 death219 reports
- Paradigm® REAL-Time Revel™ MMT-723RNAPSensor, glucose, invasive2 deaths209 reports
- Paradigm® REAL-Time Revel™ MMT-723RNALSensor, glucose, invasive2 deaths208 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASSensor, glucose, invasive1 recall3 deaths156 reports
- Paradigm® REAL-Time Revel™ MMT-523RNAHSensor, glucose, invasive206 reports
- Paradigm® REAL-Time Revel™ MMT-723LNABSensor, glucose, invasive2 deaths191 reports
- Paradigm® REAL-Time Revel™ MMT-723LNAPSensor, glucose, invasive1 death186 reports
- Paradigm® REAL-Time Revel™ MMT-523NALSensor, glucose, invasive1 death154 reports
- Paradigm® REAL-Time Revel™ MMT-723LNABSensor, glucose, invasive149 reports
- Paradigm® REAL-Time Revel™ MMT-723NAHSensor, glucose, invasive2 deaths146 reports
- Paradigm® REAL-Time Revel™ MMT-723RNAHSensor, glucose, invasive132 reports
- Paradigm® REAL-Time Revel™ MMT-723NAHSensor, glucose, invasive130 reports
- Paradigm® REAL-Time Revel™ MMT-523NABSensor, glucose, invasive129 reports
- Paradigm® REAL-Time Revel™ MMT-523LNALSensor, glucose, invasive1 death128 reports
- Paradigm® REAL-Time Revel™ MMT-523LNALSensor, glucose, invasive2 deaths127 reports
- Paradigm® REAL-Time Revel™ MMT-723LNAHSensor, glucose, invasive127 reports
- Paradigm® REAL-Time Revel™ MMT-723LNAHSensor, glucose, invasive121 reports
- Paradigm® REAL-Time Revel™ MMT-523RNABSensor, glucose, invasive4 deaths119 reports
- Paradigm® REAL-Time Revel™ MMT-723NABSensor, glucose, invasive114 reports
- Paradigm® REAL-Time Revel™ MMT-723NALSensor, glucose, invasive110 reports
- Paradigm® REAL-Time Revel™ MMT-723RNASSensor, glucose, invasive6 deaths109 reports
- Paradigm® REAL-Time Revel™ MMT-723LNAPSensor, glucose, invasive1 death107 reports
- Paradigm® REAL-Time Revel™ MMT-523NAPSensor, glucose, invasive1 death106 reports
- Paradigm® REAL-Time Revel™ MMT-723NASSensor, glucose, invasive104 reports
- Paradigm® REAL-Time Revel™ MMT-523RNALSensor, glucose, invasive1 death103 reports
- Paradigm® REAL-Time Revel™ MMT-723LNASSensor, glucose, invasive1 recall1 death50 reports
- Paradigm® REAL-Time Revel™ MMT-523RNAPSensor, glucose, invasive1 death93 reports
- Paradigm® REAL-Time Revel™ MMT-523RNASSensor, glucose, invasive91 reports
- Paradigm® REAL-Time Revel™ MMT-723NALSensor, glucose, invasive89 reports
- Paradigm® REAL-Time Revel™ MMT-523LNAPSensor, glucose, invasive89 reports
- Paradigm® REAL-Time Revel™ MMT-723NABSensor, glucose, invasive1 death87 reports
- Paradigm® REAL-Time Revel™ MMT-523LNASSensor, glucose, invasive86 reports
- Paradigm® REAL-Time Revel™ MMT-723RNAPSensor, glucose, invasive1 death82 reports
- Paradigm® REAL-Time Revel™ MMT-723LNALSensor, glucose, invasive1 death80 reports
- Paradigm® REAL-Time Revel™ MMT-523LNABSensor, glucose, invasive77 reports
- Paradigm® REAL-Time Revel™ MMT-723RNABSensor, glucose, invasive77 reports
- Paradigm® REAL-Time Revel™ MMT-523NAPSensor, glucose, invasive75 reports
- Paradigm® REAL-Time Revel™ MMT-523NASSensor, glucose, invasive72 reports
- Paradigm® REAL-Time Revel™ MMT-723NAPSensor, glucose, invasive2 deaths70 reports
- Paradigm® REAL-Time Revel™ MMT-723NAPSensor, glucose, invasive64 reports
- Paradigm® REAL-Time Revel™ MMT-523LNAHSensor, glucose, invasive1 death61 reports
- Paradigm® REAL-Time Revel™ MMT-723RNALSensor, glucose, invasive1 death61 reports
- Paradigm® REAL-Time Revel™ MMT-523RNAHSensor, glucose, invasive60 reports
- Paradigm® REAL-Time Revel™ MMT-523LNABSensor, glucose, invasive58 reports
- Paradigm® REAL-Time Revel™ MMT-523NAHSensor, glucose, invasive55 reports
- Paradigm® REAL-Time Revel™ MMT-523NALSensor, glucose, invasive55 reports
- Paradigm® REAL-Time Revel™ MMT-523NABSensor, glucose, invasive53 reports
- Paradigm® REAL-Time Revel™ MMT-723NABSensor, glucose, invasive48 reports
- Paradigm® REAL-Time Revel™ MMT-723NAHSensor, glucose, invasive1 death47 reports
- Paradigm® REAL-Time Revel™ MMT-723RNAHSensor, glucose, invasive1 death46 reports
Recent Paradigm REAL-Time Revel adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO MINIMED THAT THE CUSTOMER REPORTED THERE WAS NO DELIVERY DURING MANUAL PRIME. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-723NAS. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO DISCONTINUE DEVICE USE. MMT-723NAS WAS REQUESTED, AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25423497 ↗MalfunctionFeb 12, 2026Material Integrity Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER HAD DAMAGE TO THE PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-723NAB. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED PHYSICAL DAMAGE (CRACK OR SCRATCH) ON THE PUMP NOT RELATED TO THE RETAINER RING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. MMT-723NAB WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320489 ↗MalfunctionFeb 3, 2026Material Integrity Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED CRACKED PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-723LNAL. TROUBLESHOOTING WAS PERFORMED. DAMAGE TO PUMP WAS CAUSED BY THE CUSTOMER AND/OR BY NORMAL WEAR AND TEAR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED TO USE OF THE DEVICE, MMT-723LNAL WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24244476 ↗MalfunctionNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY. THE EVENT INVOLVED PRODUCT(S) MMT-723RNAS. TROUBLESHOOTING WAS NOT PERFORMED. THE REASON FOR CUSTOMER PASSING WAS CANCER. IT WAS UNKNOWN IF THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED. MMT-723RNAS WAS RETURNED FOR ANALYSIS.
Patient problems: Cancer
MAUDE report 23578470 ↗MalfunctionJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND CHEST PAIN. THE BLOOD GLUCOSE VALUE AT THE TIME OF THE EVENT WAS 306 MG/DL. THE CUSTOMER WAS TREATED WITH AN INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-1715K. TROUBLESHOOTING WAS PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE AUTO MODE/SMART GUARD FEATURE AT THE TIME OF THE EVENT. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-1715K WAS REQUESTED AND THE CUSTOMER'S RESPONSE WAS THAT THE DEVICE WOULD BE RETURNED.
Patient problems: Chest Pain; Hyperglycemia
MAUDE report 22409475 ↗MalfunctionFeb 20, 2025Material Integrity Problem; Material Integrity Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT CUSTOMER REPORTED PHYSICAL DAMAGE TO THE INSULIN PUMP AND CAN NO LONGER BE USED. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-723NAH, MMT-381, MMT-381, MMT-381, MMT-381, MMT-381 AND MMT-381 . TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND MMT-723NAH WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21419102 ↗MalfunctionOct 16, 2024Moisture or Humidity Problem; Moisture or Humidity Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER REPORTED MOISTURE DAMAGE TO PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT MMT-723NAS. TROUBLESHOOTING WAS PERFORMED AND ISSUE WAS UNRESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN WAS REQUESTED FOR MMT-723NAS AND INSULIN PUMP WAS RETUNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20458957 ↗DeathSep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2019. CAUSE OF DEATH WAS CANCER AND ORGAN FAILURE. TROUBLESHOOTING WAS PERFORMED AND THE PUMP WAS NOT WORN AT THE TIME OF PASSING. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE MMT-723RNAS. MMT-723RNAS WAS REQUESTED AND CUSTOMER HAS RETURNED THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 20181278 ↗DeathAug 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2020. CAUSE OF DEATH WAS HEART STROKE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: NO CONTRIBUTING FACTORS WERE IDENTIFIED AND EXPERIENCED HYPERGLYCEMIA WAS TREATED WITH HOSPITALIZATION. THE PUMP WAS NOT WORN AT THE TIME OF PASSING AND THE PUMP WAS NOT WORKING . IT WAS ALSO REPORTED CUSTOMER PASSED AWAY AT HOME. THE LAST KNOWN PRODUCT(S) FOR THIS CUSTOMER ARE AS FOLLOWS: MMT-332A, UNOMEDICAL AND MMT-723RNAS. NO PRODUCT RETURN IS REQUIRED FOR MMT-332A. NO PRODUCT RETURN IS REQUIRED FOR UNOMEDICAL AND NO PRODUCT RETURN IS REQUIRED FOR MMT-723RNAS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hyperglycemia
MAUDE report 19979782 ↗MalfunctionMay 28, 2024Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS ABOUT TO CHANGE THE INFUSION SET. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM. CUSTOMER DID NOT RECEIVE THE E70 ALARM AND THE PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC ENVIRONMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. HOWEVER, THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WAS BEEN RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19402683 ↗MalfunctionMay 24, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED TO MEDTRONIC MINIMED THAT CUSTOMER EXPERIENCED HYPERGLYCEMIA AND RECEIVED NO DELIVERY ALARM. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 348 MG/DL. THE CUSTOMER REPORTED HYPERGLYCEMIA TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). CUSTOMER REPORTED THE FOLLOWING LED UP TO THE EVENT: CUSTOMER TRIED TO BOLUS. THE EVENT INVOLVED PRODUCT(S) MMT-396 AND MMT-723NAS. THE TROUBLESHOOTING WAS PERFORMED. CUSTOMER DECLINED TO CONTINUE WITH TROUBLESHOOTING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-396 WAS REQUESTED AND THE CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED. NO PRODUCT RETURN IS REQUIRED FOR MMT-723NAS.
Patient problems: Hyperglycemia
MAUDE report 19390501 ↗MalfunctionMay 20, 2024Break; Break
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED DAMAGE (PHYSICAL OR COSMETIC). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-723LNAS. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-723LNAS WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19351477 ↗MalfunctionMay 12, 2024Power Problem; Power Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED UNEXPECTED BATTERY POWER LOSS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE TROUBLESHOOTING WAS PERFORMED. THE EVENT INVOLVED PRODUCT(S) MMT-523NAP. REPORTED ISSUE RESOLVED NO ESCALATION REQUIRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. NO PRODUCT RETURN IS REQUIRED FOR MMT-523NAP. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE OR DISCONTINUE TO USE OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19295628 ↗MalfunctionJan 30, 2024Battery Problem; Battery Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTS A HALF BATTERY LIFE AND DEAD BATTERY WITHOUT ALARM AND A HIGH BG OF 217 MG/DL. TROUBLESHOOTING WAS PERFORMED AND NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. ADVISED CUSTOMER TO DISCONTINUE PUMP AND REVERT BACK TO HCP¿S INSTRUCTIONS. THE INSULIN PUMP WILL BE REPLACED. THE INSULIN PUMP WAS RETURNED FOR PRODUCT ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 18604513 ↗InjuryJan 10, 2024Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A MOTOR ERROR DURING THE REWIND. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND THE PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 18481889 ↗
Other Medtronic Minimed, Inc. products
- MiniMed 670G23 models · 141,169 reports · 4 recalls
- MiniMed 630G23 models · 65,972 reports · 6 recalls
- MiniMed 530G71 models · 48,745 reports · 1 recall
- MiniMed670G2 models · 28,871 reports · 3 recalls
- MiniMed630G2 models · 6,656 reports · 5 recalls
- MiniMed Reservoir6 models · 4,545 reports
- PARADIGM REAL-time95 models · 2,862 reports · 1 recall
- Guardian Sensor (3)11 models · 2,726 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page