Guardian™ Link (3) MMT-7811NA (UDI 00763000215538)Recalls & reported problems
Medtronic Minimed, Inc. · RPL MMT-7811NA GST3C LOCKOUT 2.2A ARM · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000215538), received between Jul 5, 2019 and Apr 24, 2023 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (3 reports).
14 other recalls cover devices cleared under the same FDA submission (P160017); 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 16, 2026.
Most reported problems
Device problems
- Communication or Transmission Problem3
- Wireless Communication Problem3
- Adverse Event Without Identified Device or Use Problem2
- Calibration Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Hyperglycemia1
- No Consequences Or Impact To Patient1
- Skin Inflammation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2023Wireless Communication Problem; Wireless Communication Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THE CUSTOMER REPORTED LOSS OF COMMUNICATION. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. PUMP WILL BE RETURN FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16794552 ↗MalfunctionApr 19, 2023Communication or Transmission Problem; Wireless Communication Problem; Communication or Transmission Problem; Wireless Communication Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD A LOSS OF COMMUNICATION ISSUE BETWEEN THE PUMP AND THE TRANSMITTER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CORRECT TRANSMITTER ID WAS PROGRAMMED INTO THE PUMP AND THE ISSUE WAS NOT RESOLVED. PRODUCT WILL BE RETURN FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16767702 ↗MalfunctionApr 19, 2023Communication or Transmission Problem; Wireless Communication Problem; Communication or Transmission Problem; Wireless Communication Problem
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD A LOSS OF COMMUNICATION ISSUE BETWEEN THE PUMP AND THE TRANSMITTER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CORRECT TRANSMITTER ID WAS PROGRAMMED INTO THE PUMP, BUT THE ISSUE WAS NOT RESOLVED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766468 ↗MalfunctionMay 5, 2020Calibration Problem; Calibration Problem
INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 112 MG/DL AND SENSOR GLUCOSE WAS 41 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE IS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 41 MG/DL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10023852 ↗InjuryOct 17, 2019Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 416 MG/DL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 416 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED THAT THE HIGH BLOOD GLUCOSE LEVELS BEGAN ON (B)(6) 2019. THE CUSTOMER DID NOT STATE HOW THEY TREATED HYPERGLYCEMIA. THE CUSTOMER STATES THAT THEY WERE CHANGING TRANSMITTER AT THE TIME. THE PRODUCT WAS RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 9201165 ↗InjuryJul 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY FELT PAIN ON INSERTION SITE, CONSULTED WITH THERE DOCTOR AND APPEARED THAT THERE WAS BURN ON SITE DUE TO TRANSMITTER. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THERE WAS BURN ON SITE WHICH CAUSE BLISTERS WHICH LEADS TO GET HER SOME MEDICINES. TRANSMITTER WILL BE RETURNED FOR ANALYSIS.
Patient problems: Skin Inflammation
MAUDE report 8763216 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P160017. One submission often covers many models, so check the product and lot details in each record.
- Z-2981-2026 · Jul 13, 2026 · Open, ClassifiedMiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
- Z-1742-2026 · Feb 13, 2026 · Open, ClassifiedMiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
- Z-1739-2026 · Feb 13, 2026 · Open, ClassifiedMiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
- Z-1261-2025 · Jan 31, 2025 · Open, ClassifiedMiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
- Z-1265-2025 · Jan 31, 2025 · Open, ClassifiedMiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
- Z-1266-2025 · Jan 31, 2025 · Open, ClassifiedMiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
- Z-0003-2025 · Jul 31, 2024 · Open, ClassifiedMiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G
- Z-0193-2023 · Sep 20, 2022 · Open, ClassifiedInsulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742
- Z-0855-2022 · Jan 27, 2022 · Open, ClassifiedMiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-18
- Z-1771-2021 · Mar 15, 2021 · Open, ClassifiedMiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE
- Z-0516-2021 · Apr 30, 2020 · Open, ClassifiedMiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under
- Z-0956-2020 · Nov 21, 2019 · Open, ClassifiedMedtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MM
- Z-2604-2017 · May 8, 2017 · TerminatedMiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
- Z-2605-2017 · May 8, 2017 · TerminatedMiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
Other Automated insulin dosing device system, single hormonal control devices
- MiniMed® 670G MMT-1780KPKMedtronic Minimed, Inc. · Artificial pancreas device system, single hormonal control3 recalls78 deaths55,723 reports
- MiniMed® 670G MMT-1780KPKMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control2 recalls51 deaths33,713 reports
- MiniMed®670G MMT-1780KPKMedtronic Minimed, Inc. · Artificial pancreas device system, single hormonal control3 recalls39 deaths28,789 reports
- MiniMed® 670G MMT-1780KLMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control3 recalls8 deaths8,353 reports
- MiniMed® 670G MMT-1780KMedtronic Minimed, Inc. · Artificial pancreas device system, single hormonal control3 recalls7 deaths6,776 reports
- MiniMed® 670G MMT-1780KPKMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control3 recalls10 deaths4,325 reports
- MiniMed™ Reservoir MMT-332AMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control2 deaths3,013 reports
- Guardian™ Sensor (3) MMT-7020AMedtronic Minimed, Inc. · Automated insulin dosing device system, single hormonal control1,304 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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