MiniMed® 530G MMT-751PNABRecalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-751PNAB PRDGM V3.0 BL US PW · Class 3
All models of MiniMed 530G (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The Medtronic MiniMed 530G is an insulin pump that can pause insulin delivery when glucose falls low. Twenty-six reports, filed between June 2017 and June 2020, describe buttons sticking or not responding, motor errors, slow priming, battery drain, cracked screens, and unexpected no-delivery alarms; some reports mention high blood sugar or ketones. There were no deaths and 7 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
- 26
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00643169507319), received between Jun 14, 2017 and Jun 8, 2020 — classified as 7 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (6 reports).
2 other recalls cover devices cleared under the same FDA submission (P120010); 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 Difficult to Program or Calibrate6
- Device Displays Incorrect Message6
- Patient Device Interaction Problem6
- Mechanical Problem4
- Adverse Event Without Identified Device or Use Problem3
- No Display/Image3
- Priming Problem3
- Battery Problem2
Patient problems
- No Consequences Or Impact To Patient16
- Hyperglycemia9
- Elevated Ketones/ Diabetic Ketoacidosis1
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Priming Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERRORS AND THE ACT BUTTON WAS STICKING. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS SLOW TO PRIME AND HAD TO RESTART TO COMPLETE. THE CUSTOMER STATED THAT THEY HAD TO CHANGE BATTERY FREQUENTLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10127307 ↗MalfunctionApr 8, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE KEYPAD ANOMALY THAT IS THE UP AND DOWN BUTTON NOT WORKING. THE CUSTOMER ALSO REPORTED THAT THE TIME ADVANCES. 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 9937377 ↗MalfunctionApr 3, 2020Device Alarm System; Patient Device Interaction Problem; Device Alarm System; Patient Device Interaction Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S BATTERIES DYING BATTERY CRACK ON SCREEN RIGHT HAND CORNER AROUND THE BACK ALARM SOUND WAS WEAK AND HE WAS HEARING IMPAIRED 24 HR DECLINE. 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 9921859 ↗MalfunctionOct 16, 2019Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR AND MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 230 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM AND ABLE TO COMPLETE INSULIN PUMP REWIND. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9197349 ↗MalfunctionAug 20, 2019Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE UP BUTTON WAS NON RESPONSIVE AND ACT BUTTON WAS SOMETIMES UNRESPONSIVE AS WELL ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WAS REJECTED BATTERY ONCE OR TWICE, HAIRLINE CRACK ON SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8913801 ↗MalfunctionAug 13, 2019Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES BATTERY LIFE WAS DIMINISHED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8886337 ↗MalfunctionJun 21, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER ALSO STATED THAT THE PRIMING AND REWINDING ISSUE. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8721675 ↗MalfunctionApr 26, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE ISSUES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER REPORTED THAT BUTTON WAS HARD TO PUSH, STICKY AND SOMETIMES UNRESPONSIVE. THEY ALSO COMPLAINED OF UNEXPLAINED OR RANDOM NO DELIVERY ALARM, SCRATCHES, DAMAGE, AND THE RAINBOW EFFECT ON THE SCREEN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8553782 ↗InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 35 MG/DL,135 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD. THE CUSTOMER DECLINED TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8456640 ↗MalfunctionFeb 26, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR COMPARTMENT WAS BROKEN. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8369235 ↗InjuryNov 14, 2018Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 500 MG/DL. THE CUSTOMER WAS HOSPITALIZED DUE TO NON DIABETIC REASON. THE CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH INTRAVENOUS DRIP. CUSTOMER ALSO REPORTED THAT THE UP ARROW, DOWN ARROW AND ESC BUTTONS. CUSTOMER STATED THAT THE TIME WAS ADVANCED. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8068218 ↗MalfunctionSep 26, 2018Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 87 MG/DL AT THE TIME OF THE INCIDENT. 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: No Consequences Or Impact To Patient
MAUDE report 7913096 ↗MalfunctionJul 12, 2018Priming Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD NO DELIVERY ALARMS, REWIND ANOMALY AND INSULIN WAS SQUIRTING DURING PRIMING. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7680592 ↗InjuryApr 12, 2018Device Displays Incorrect Message
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 560 MG/DL. CUSTOMER REPORTED THAT THEY HAD ISSUE WITH THE PUMP ALARMING NO DELIVERY. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS UNABLE TREATED BECAUSE HE DID NOT HAVE A BACKUP PLAN. CUSTOMER WILL NOT RETURN DEVICE FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7425950 ↗MalfunctionApr 6, 2018No Display/Image
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 142 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7405315 ↗InjuryApr 5, 2018No Display/Image; Device Inoperable
THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A FROZEN DISPLAY AND BLANK DISPLAY ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 302 MG/DL AT THE TIME OF INCIDENT AND TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP WAS FROZEN AND THE BUTTONS WERE UNRESPONSIVE. CUSTOMER CONFIRMED THAT THE TIME IS NOT ADVANCING AND THE BUTTONS REMAINED UNRESPONSIVE AFTER BATTERY CHANGE.. CUSTOMER HAD A BLANK DISPLAY THAT WAS RESOLVED BY BATTERY REPLACEMENT. IT WAS ALSO MENTIONED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. 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 7401597 ↗InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND KETOACIDOSIS WITH BLOOD GLUCOSE OF 700 MG/DL, THE CUSTOMER CURRENT BLOOD GLUCOSE WAS 400 MG/DL. THE CUSTOMER WAS HOSPITALIZED AT 12AM. THE DRIVE SUPPORT CAP APPEARS NORMAL (SLIGHTLY INDENTED).THE CUSTOMER WAS TREATED WITH WENT TO HOSPITAL. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 7362605 ↗MalfunctionFeb 9, 2018Device Operates Differently Than Expected
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. IT ALSO REPORTED THAT THE AFTER INSERTION OF NEW BATTERY RECEIVED UNEXPECTED RESTART ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7262136 ↗InjuryFeb 7, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 541 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING ON INSULIN PUMP FOR HIGH BLOOD GLUCOSE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER REPORTED THAT THE THEY RECEIVED NO DELIVERY ALARM AND INSULIN WAS EXITED DURING PRIME. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7250267 ↗InjuryJan 23, 2018Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 450 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING ON INSULIN PUMP. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION AND BOLUS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7213949 ↗MalfunctionOct 5, 2017Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND MOTOR POSITION ENCODER ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. 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: No Consequences Or Impact To Patient
MAUDE report 6915177 ↗MalfunctionSep 21, 2017Break
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. CUSTOMER STATES THAT THE DAMAGE OCCURRED ON TOP OF THE PUMP WHERE RESERVOIR IS INSERTED PART OF THE PLASTIC ON THE ACTUAL PUMP HAS COME OFF HENCE UNABLE TO RESERVOIR IN THE PUMP. CUSTOMER PERFORMED TROUBLESHOOT FOR PHYSICAL DAMAGE. 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 6883630 ↗MalfunctionSep 6, 2017No Display/Image
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN LCD SCREEN WHICH HAS BLUE AND BLACK CLOUDS ON THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES THE LCD SCREEN HAS A BLARE MAKING IT HARD TO READ. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CUSTOMER CAN READ THE SCREEN BUT DOES HAVE SOME ISSUES WHEN IT STARTS TO BLUR. 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 6847395 ↗MalfunctionJun 29, 2017Sticking; Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD MULTIPLE NO DELIVERY ALARMS FOR THE LAST 3 DAYS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THE ALARM DID NOT OCCUR DURING THE MANUAL PRIME. THE CUSTOMER REPORTED THAT THE EVENT WAS RESOLVED BY CHANGING THE COMPLETE INFUSION AND RESERVOIR SET. THE CUSTOMER DID NOT HAVE THE PRODUCT IN QUESTION TO RETURN. THE CUSTOMER ALSO REPORTED THAT THEY HAD A STUCK BUTTON. WHEN THEY TRIED TO CLEAR THE ALARMS, THE UP ARROW BUTTON WAS STICKING. IT WAS STUCK AND IT KEPT FLIPPING BACK AND FORTH BETWEEN THE OPTIONS ON THE INSULIN PUMP. THEY WERE ADVISED TO OBSERVE THE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES. THE CUSTOMER VERIFIED THAT TIME ADVANCED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 6677508 ↗MalfunctionJun 22, 2017Failure to Read Input Signal; Device Displays Incorrect Message; Noise, Audible
IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP IS MAKING A HIGH PITCHED NOISE, HAS A LOW BATTERY ALERT AND NONE OF THE BUTTONS ARE RESPONDING. THE TIME ADVANCES ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED ON THE INSULIN PUMP FOR THE LOW BATTERY AND THE BATTERY LASTED MORE THAN ONE WEEK. THE CUSTOMER WOKE UP TO A BLOOD GLUCOSE OF 56 MG/DL AND THE INSULIN PUMP ALARMING THRESHOLD SUSPEND. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE THRESHOLD SUSPEND AND WILL BE RETURNING THE PUMP. THE CURRENT BLOOD GLUCOSE IS 85 MG/DL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6660828 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P120010. One submission often covers many models, so check the product and lot details in each record.
- Z-1751-2026 · Feb 13, 2026 · Open, ClassifiedMiniMed 530G Insulin Pump (MMT-551, MMT-751)
- 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 Artificial pancreas device system, threshold suspend devices
- t:slim X2 Insulin Pump with Basal-IQ 1000886Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall17 deaths108,656 reports
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend4 recalls98 deaths35,170 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000912Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall2 deaths30,219 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000898Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall6 deaths16,106 reports
- MiniMed® 630G MMT-1715KMMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend2 recalls50 deaths9,892 reports
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Automated insulin dosing , threshold suspend4 recalls36 deaths7,947 reports
- MiniMed® 530G MMT-751NASMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend36 deaths7,479 reports
- MiniMed®630G MMT-1715KMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend2 recalls17 deaths6,645 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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