PARADIGM REAL-timeRecalls & reported problems across all models
Medtronic Minimed, Inc. · 95 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one PARADIGM REAL-time model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,862
- Deaths reported
- 24
- Injuries reported
- 637
- Recalls
- 1
We found 95 models of PARADIGM REAL-time by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). Together they are named in 2,862 adverse event reports in the FDA's MAUDE database, received between May 5, 2017 and Jun 4, 2026 — classified as 24 deaths, 637 injuries, 2,201 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (603 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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 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-1749-2026 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗
Most reported PARADIGM REAL-time problems
Device problems
- Device Displays Incorrect Message603
- Device Difficult to Program or Calibrate420
- Mechanical Problem346
- Failure to Cycle294
- Patient Device Interaction Problem285
- Adverse Event Without Identified Device or Use Problem235
- No Display/Image195
- Detachment of Device or Device Component194
Patient problems
- No Consequences Or Impact To Patient1,954
- Hyperglycemia709
- Hypoglycemia178
- Elevated Ketones/ Diabetic Ketoacidosis37
- Death32
- No Known Impact Or Consequence To Patient22
- No Clinical Signs, Symptoms or Conditions10
- Nausea6
PARADIGM REAL-time models
95 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PARADIGM® REAL-time MMT-722LNASSensor, glucose, invasive1 recall1 death368 reports
- PARADIGM® REAL-time MMT-722NALSensor, glucose, invasive1 death290 reports
- PARADIGM® REAL-time MMT-722NASSensor, glucose, invasive1 recall2 deaths208 reports
- PARADIGM® REAL-time MMT-722NASSensor, glucose, invasive1 recall1 death208 reports
- PARADIGM® REAL-time MMT-722LNALSensor, glucose, invasive1 death170 reports
- PARADIGM® REAL-time MMT-722LNABSensor, glucose, invasive164 reports
- PARADIGM® REAL-time MMT-522LNASSensor, glucose, invasive3 deaths131 reports
- PARADIGM® REAL-time MMT-722LNAPSensor, glucose, invasive118 reports
- PARADIGM® REAL-time MMT-722NALSensor, glucose, invasive106 reports
- PARADIGM® REAL-time MMT-522NASSensor, glucose, invasive85 reports
- PARADIGM® REAL-time MMT-522LNALSensor, glucose, invasive67 reports
- PARADIGM® REAL-time MMT-722LNAHSensor, glucose, invasive62 reports
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive2 deaths60 reports
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive50 reports
- PARADIGM® REAL-time MMT-522LNABSensor, glucose, invasive50 reports
- PARADIGM® REAL-time MMT-722NASSensor, glucose, invasive3 deaths43 reports
- PARADIGM® REAL-time MMT-722NALSensor, glucose, invasive43 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive42 reports
- PARADIGM® REAL-time MMT-522LNAPSensor, glucose, invasive37 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive1 death33 reports
- PARADIGM® REAL-time MMT-722NASSensor, glucose, invasive33 reports
- PARADIGM® REAL-time MMT-722NASSensor, glucose, invasive1 death27 reports
- PARADIGM® REAL-time MMT-522NASSensor, glucose, invasive23 reports
- PARADIGM® REAL-time MMT-522LNAHSensor, glucose, invasive22 reports
- PARADIGM® REAL-time MMT-722NAHSensor, glucose, invasive22 reports
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive1 death22 reports
- PARADIGM® REAL-time MMT-522NALSensor, glucose, invasive21 reports
- PARADIGM® REAL-time MMT-722NASSensor, glucose, invasive20 reports
- PARADIGM® REAL-time MMT-522NABSensor, glucose, invasive20 reports
- PARADIGM® REAL-time MMT-522NASSensor, glucose, invasive2 deaths19 reports
- PARADIGM® REAL-time MMT-722RNASSensor, glucose, invasive19 reports
- PARADIGM® REAL-time MMT-722NASSensor, glucose, invasive16 reports
- PARADIGM® REAL-time MMT-522NAPSensor, glucose, invasive14 reports
- PARADIGM® REAL-time MMT-722RNASSensor, glucose, invasive1 death14 reports
- PARADIGM® REAL-time MMT-522NASSensor, glucose, invasive1 death13 reports
- PARADIGM® REAL-time MMT-522NAPSensor, glucose, invasive11 reports
- PARADIGM® REAL-time MMT-522NASSensor, glucose, invasive10 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive10 reports
- PARADIGM® REAL-time MMT-522NABSensor, glucose, invasive1 death10 reports
- PARADIGM® REAL-time MMT-722RNABSensor, glucose, invasive10 reports
- PARADIGM® REAL-time MMT-722NALSensor, glucose, invasive8 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive8 reports
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive7 reports
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive6 reports
- PARADIGM® REAL-time MMT-522NALSensor, glucose, invasive6 reports
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive6 reports
- PARADIGM® REAL-time MMT-522NABSensor, glucose, invasive6 reports
- PARADIGM® REAL-time MMT-522NAHSensor, glucose, invasive6 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive6 reports
- PARADIGM® REAL-time MMT-522NALSensor, glucose, invasive5 reports
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive5 reports
- PARADIGM® REAL-time MMT-522RNASSensor, glucose, invasive5 reports
- PARADIGM® REAL-time MMT-722RNAPSensor, glucose, invasive5 reports
- PARADIGM® REAL-time MMT-522RNASSensor, glucose, invasive5 reports
- PARADIGM® REAL-time MMT-722NALSensor, glucose, invasive4 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive4 reports
- PARADIGM® REAL-time MMT-722NALSensor, glucose, invasive4 reports
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive4 reports
- PARADIGM® REAL-time MMT-522NALSensor, glucose, invasive4 reports
- PARADIGM® REAL-time MMT-522NAPSensor, glucose, invasive4 reports
- PARADIGM® REAL-time MMT-522NASSensor, glucose, invasive3 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive3 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive3 reports
- PARADIGM® REAL-time MMT-522RNABSensor, glucose, invasive3 reports
- PARADIGM® REAL-time MMT-722RNALSensor, glucose, invasive3 reports
- PARADIGM® REAL-time MMT-522NALSensor, glucose, invasive3 reports
- PARADIGM® REAL-time MMT-522RNABSensor, glucose, invasive3 reports
- PARADIGM® REAL-time MMT-722RNABSensor, glucose, invasive1 death3 reports
- PARADIGM® REAL-time MMT-722NAPSensor, glucose, invasive3 reports
- PARADIGM® REAL-time MMT-522PNASSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-722PNASSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-722LNASSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-722PNALSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-522RNASSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-522RNAPSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-522RNALSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-522NABSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-722RNALSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-722RNAPSensor, glucose, invasive2 reports
- PARADIGM® REAL-time MMT-722PNABSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-722PNALSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-722PNAPSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-522NALSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-722NABSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-722LNABSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-522LNASSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-722KNSSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-722PNABSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-522LNASSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-522RNABSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-522PNASSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-522PNABSensor, glucose, invasive1 death1 report
- PARADIGM® REAL-time MMT-722PNALSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-722RNAHSensor, glucose, invasive1 report
- PARADIGM® REAL-time MMT-722NAHSensor, glucose, invasive1 report
Recent PARADIGM REAL-time adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Key or Button Unresponsive/not Working
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED RECEIVED THE BUTTON ERROR ALARM IN THE INSULIN PUMP. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-522LNAP. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE INSULIN PUMP. MMT-522LNAP WAS REQUESTED AND THE DEVICE WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25390733 ↗MalfunctionDec 8, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER REPORTED DAMAGE. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-722NAS. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. MMT-722NAS WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741589 ↗MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED THAT THE PUMP HAS A CRACK. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-522RNAS. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT PUMP HAS A DAMAGE AT RESERVOIR WINDOW, BETWEEN WINDOW AND ESC BUTTON. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER WILL DISCONTINUE TO USE THE PUMP. PRODUCT MMT-522RNAS WAS REQUESTED AND PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23678380 ↗MalfunctionMay 19, 2025Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED BUTTON ERROR. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-722LNAS. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. CUSTOMER DISCONTINUED USE OF THE INSULIN PUMP. MMT-722LNAS WAS REQUESTED AND CUSTOMER RESPONDED THE DEVICE WAS RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22044965 ↗MalfunctionSep 1, 2023Break; Break
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A DAMAGE TO THE PUMP. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17667735 ↗MalfunctionJun 19, 2023Break; Obstruction of Flow; Break; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED INSULIN PUMP HAD A CRACK AND NO DELIVERY ALARMS. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT DAMAGE WAS ON THE RESERVOIR AREA AND THE RESERVOIR WAS ABLE TO LOCK IN PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17149756 ↗MalfunctionFeb 20, 2023Break; Power Problem; Break; Power Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATES THAT THE CUSTOMER HAD A SCRATCH ON THE SCREEN AND ALSO PUMP REJECTED NEW BATTERIES. THE CUSTOMER ALSO FOUND THAT BATTERY CAP AREA WAS LITTLE TIGHTER TO SCREW ON. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16402045 ↗MalfunctionJul 18, 2022Power Problem; Power Problem
MEDTRONIC RECEIVED INFORMATION THAT LOW BATTERY ALERT LESS THAN 1 WEEK OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15040629 ↗MalfunctionApr 12, 2022Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER HAD RECEIVED MOTION SENSOR TEST FAILURE ERROR. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE TO USE THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14080097 ↗MalfunctionMar 24, 2022Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL CONTINUE TO USE THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13890761 ↗MalfunctionJul 20, 2021Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A RECURRING MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE DEVICE WAS NOT EXPOSED TO STRONG MAGNETIC FIELD AND THE DRIVE SUPPORT CAP APPEARED NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: Insufficient Information
MAUDE report 12194653 ↗MalfunctionNov 24, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. THE DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10896883 ↗MalfunctionOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER'S WIFE WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS SEVERE CARDIAC ARREST. THE CALLER DID NOT STATE WHETHER THE CUSTOMER HAD ANY OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED MORE THAN 48 HOURS PRIOR TO PASSING. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. PUMP HAD UNEXPECTED VIBRATOR NOISE DURING VIBRATE CHECK DUE TO ADHESIVE NOT ADHERING THE VIBRATOR MOTOR TO THE CASE. THIS REPORT WAS CREATED FOR THE FAILURE ANALYSIS RESULTS.
Patient problems: Death
MAUDE report 10689332 ↗MalfunctionOct 16, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR INSULIN PUMP HAD MOTOR ERROR ALARM AND NO DELIVERY ALARMS. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT RECEIVE MOTOR POSITION ENCODER ALARM. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO COMPLETE REWIND THE INSULIN PUMP. 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 10688445 ↗MalfunctionOct 8, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR. CUSTOMER STATED DRIVE SUPPORT CAP APPEARED NORMAL-SLIGHTLY INDENTED. CUSTOMER STATED THEY WERE ABLE TO SUCCESSFULLY CLEAR THE ALARM AND WERE ABLE TO REWIND. 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 10653735 ↗
Other Medtronic Minimed, Inc. products
- MiniMed 670G23 models · 141,169 reports · 4 recalls
- MiniMed 630G23 models · 65,972 reports · 6 recalls
- Paradigm REAL-Time Revel180 models · 49,838 reports · 2 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
- 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