MiniMed® 530G MMT-751PNAL (UDI 00643169507333)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-751PNAL PRDGM V3.0 CL US PW · Class 3
All models of MiniMed 530G (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic MiniMed 530G insulin pump, an artificial pancreas system that pauses insulin delivery when blood sugar drops too low. Reports mostly describe the pump showing error messages, alarms it would not clear, buttons becoming hard to press, and cracked cases, along with blood sugar running high or low. There are 46 reports, including 1 death and 18 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
- 46
- Deaths reported
- 1
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00643169507333), received between Jun 8, 2017 and Jun 23, 2020 — classified as 1 death, 18 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (10 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 Displays Incorrect Message10
- Adverse Event Without Identified Device or Use Problem8
- Device Difficult to Program or Calibrate5
- Mechanical Problem5
- No Apparent Adverse Event4
- Obstruction of Flow3
- Patient Device Interaction Problem3
- Failure to Cycle2
Patient problems
- No Consequences Or Impact To Patient20
- Hyperglycemia19
- Hypoglycemia7
- No Known Impact Or Consequence To Patient2
- Death1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM BUT NOT ABLE TO COMPLETE REWIND PROCESS. 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 10184809 ↗MalfunctionApr 28, 2020Mechanical Problem; Mechanical Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10007887 ↗MalfunctionSep 16, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Mechanical Problem; Obstruction of Flow; Battery Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE BATTERY LIFE WAS DIMINISHED TO ABOUT TWO WEEKS AND HAD UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9070226 ↗MalfunctionMay 29, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8648955 ↗MalfunctionMay 8, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA THE PHONE CALL THAT THE UP ARROW WAS HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE UP BUTTON HAD BEEN ACTING UP FOR A COUPLE OF MONTHS AND SEEM TO HAVE GOTTEN WORSE. 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 NEED TO BE REPLACED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8590451 ↗MalfunctionMay 4, 2019Obstruction of Flow; Moisture or Humidity Problem; Obstruction of Flow; Moisture or Humidity Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 249 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER STATES THE INSULIN PUMP WAS EXPOSED TO FLUID/MOISTURE WHEN HE JUMPED INTO THE POOL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8580461 ↗MalfunctionApr 26, 2019Failure 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 150 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER TROUBLESHOOTING WAS PERFORMED. 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 8553821 ↗MalfunctionApr 22, 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 THE INSULIN PUMP HAD CRACK ON CASE AND KEYPAD ANOMALY. THE BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN PUMP REQUIRES MORE THAN ONE REWIND WITH RESERVOIR CHANGE, BUTTON WAS HARDER TO PRESS, PUMP HAS BECOME UNRESPONSIVE DURING BATTERY CHANGE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8534594 ↗InjuryApr 3, 2019Excess Flow or Over-Infusion; No Apparent Adverse Event; Excess Flow or Over-Infusion; No Apparent Adverse Event
CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 40 MG/DL TO 450 MG/DL. CUSTOMER RESPONSE STATED THE INSULIN PUMP HAD BEEN GIVING HER TOO MUCH INSULIN AND CUSTOMER HAD TO SHUT IT DOWN TWICE IN THE LAST COUPLE OF DAY AND ALSO REPORT CRACK IN INSULIN PUMP CASING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 8477047 ↗InjuryMar 30, 2019Insufficient Flow or Under Infusion; No Apparent Adverse Event; Patient Device Interaction Problem; Insufficient Flow or Under Infusion; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE AND LOW BLOOD GLUCOSE VALUE OF 43 MG/DL AND 450 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE VALUE WAS 94 MG/DL. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS OVER DELIVERING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION AND BOLUS FOR HIGH BLOOD GLUCOSE AND CARBOHYDRATE FOR LOW BLOOD GLUCOSE. CUSTOMER REPORTED CRACK IN PUMP CASING. THE INSULIN PUMP WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia; Hypoglycemia
MAUDE report 8467506 ↗MalfunctionDec 7, 2018Failure to Cycle; Failure to Cycle
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT INSULIN WAS SQUIRTED OUT DURING PRIMING PROCESS. CUSTOMER STATES INSULIN CONTINUES TO DRIP AFTER MOTOR STOPS DURING THE MANUAL PRIME PROCESS. DRIVE SUPPORT CAP WAS NORMAL. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8141551 ↗InjuryDec 3, 2018Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 1770 MG/DL. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM DURING BOLUS. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8125404 ↗MalfunctionNov 26, 2018Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Power Problem; Priming Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Power Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY PRIME ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD REJECTED A BRAND NEW BATTERY BEFORE DURING PRIMING AND IT WAS LEAKED AND DRIPS MORE THAN IT SHOULD. THE CUSTOMER REPORTED THAT THE BUTTONS WERE NOT AS RESPONSIVE; HARDER TO SEE SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8101115 ↗InjuryOct 9, 2018No Apparent Adverse Event; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE HYPERGLYCEMIA. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 408 MG/DL AT THE TIME OF INCIDENT. CUSTOMER¿S CURRENT BLOOD GLUCOSE IS 126 MG/DL. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATED THAT THEY WERE NOT ABLE TO COMPLETE THE REWIND. THE CUSTOMER STATED THAT CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER DID NOT EXPERIENCES ANY SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE UNDER DELIVERY. THE CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7947123 ↗MalfunctionOct 2, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND FAILED BATTERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD DIMINISHED BATTERY LIFE, REJECTED NEW BATTERY A FEW TIMES, BUTTONS STICKING AND REQUIRE MULTIPLE PRESSES CAUSING WRONG. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7924990 ↗InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED A HIGH BLOOD GLUCOSE AS WELL AS INSULIN PUMP HAD A BLANK DISPLAY. BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT IS 510 MG/DL AND WAS TREATED WITH MANUAL INJECTION. PRODUCT WILL BE RETURNED FOR ANALYSIS AND REPLACEMENT HAS BEEN SENT.
Patient problems: Hyperglycemia
MAUDE report 7863186 ↗MalfunctionAug 28, 2018Priming Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP BUTTONS ARE UNRESPONSIVE AND NO DELIVERY ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER DECLINED TO TRANSFER TO HELPLINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7825306 ↗MalfunctionAug 28, 2018Patient Device Interaction Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP GOT SCRATCHES ON THE SCREEN AND THEY WERE UNABLE TO READ THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7823297 ↗MalfunctionJun 29, 2018Loss of Power
THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD REWINDING ANOMALY AND UNEXPECTED BATTERY POWER LOSS. CUSTOMER CANNOT RECALL THEIR BLOOD GLUCOSE READING. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7653667 ↗DeathJun 14, 2018Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST AND DIABETES. THE CALLER STATED THAT THE CUSTOMER HAD ATHEROSCLEROTIC CARDIOVASCULAR ISSUES, PERIPHERAL ARTERIAL ISSUES, HYPERTENSION, DYSLIPIDEMIA, COPD, AND SLEEP APNEA THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.
Patient problems: Death
MAUDE report 7603455 ↗MalfunctionApr 10, 2018Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE FAILED BATTER ALARM. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7415654 ↗MalfunctionMar 22, 2018No Display/Image; Device Displays Incorrect Message
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND ALSO REPORTED THAT, THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS 308 MG/DL AT THE TIME OF THE INCIDENT. ISSUE WAS NOT RESOLVED BY TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7361686 ↗MalfunctionMar 9, 2018Break; Detachment Of Device Component
CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD RING LIP PART OF THE RESERVOIR COMPARTMENT BROKE OFF. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 188 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7329350 ↗InjuryFeb 26, 2018Device Operates Differently Than Expected
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD FAILED BATTERY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 458 MG/DL. THE CUSTOMER TREATED WITH MANUAL INJECTION. TROUBLESHOOT FOR FAILED BATTERY TEST ALARM WAS PERFORMED AND CUSTOMER REPORTED THAT HE DID NOT RECEIVE FAILED BATTERY TEST. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 7298440 ↗InjuryJan 12, 2018Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL MG/DL. THE CUSTOMER BLOOD GLUCOSE AT TIME OF INCIDENT WAS 35 MG/DL AND CURRENT BLOOD GLUCOSE WAS 116 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 7186464 ↗
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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