Guardian™ Sensor (3) MMT-7020A (UDI 20763000337005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20763000337005), received between Jul 28, 2020 and Mar 24, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (P160007); 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Therapeutic or Diagnostic Output Failure

  MEDTRONIC GUARDIAN SENSOR (3) FAILED. INSERTED A NEW SENSOR ON THE MORNING OF (B)(6) 2021 AND WAS GOING THROUGH THE CALIBRATION PROCESS. THE SENSOR READING AT 9:01 PM WAS 113 AND MY ACTUAL BG WAS 193. I HAVE NOW HAD 6 OUT OF 9 SENSORS OF LOT HG50LUF (REF (B)(4)) FAIL. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Hyperglycemia

  MAUDE report 11568461 ↗
• InjuryMar 16, 2021Activation, Positioning or Separation Problem

  I WAS SETTING UP TO INSERT A NEW MEDTRONIC GUARDIAN SENSOR (3) WHEN A CLEAR PLASTIC PART OF THE SENSOR DID NOT SEPARATE FROM THE TAP. I HAVE HAD SEVERAL ISSUES WITH THIS LOT NUMBER OF SENSOR SO I DID NOT WANT TO USE THE SENSOR AND HAVE IT FAIL. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11506763 ↗
• MalfunctionMar 16, 2021Low Test Results; Separation Failure

  THIS IS THE SECOND SENSOR THAT I HAD TO REPLACE TODAY (MEDTRONIC GUARDIAN SENSOR (3)). DURING CALIBRATION, SENSOR WAS READING 72 ACTUAL BLOOD SUGAR WAS 111. SENSOR WAS READING BETWEEN 60-72 FOR 2 HOURS. I HAVE CONTACTED MEDTRONIC SEVERAL TIME BECAUSE I BELIEVE THAT THERE IS AN ISSUE WITH LOT HG50LUF. I HAVE THREE BOXES OF THIS SAME LOT NUMBER, THREE SENSOR OF THE FIRST BOX FAILED AND NOW 2 SENSORS OF THE SECOND BOX. I AM SENDING THE SENSOR WHERE THE CLEAR PLASTIC PART DID NOT SEPARATE FROM THE TAP BACK TO MEDTRONIC AS WELL AS THE REMAINING TWO SENSORS IN THE BOX. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11505326 ↗
• MalfunctionMar 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Material Twisted/Bent

  SENSOR FAILURE OF MEDTRONIC GUARDIAN SENSOR (3). WAS NOT READING BG ACCURATELY FILAMENT WAS BENT. REF - MMT-7020A. DID NOT REPLACE SENSOR WITH A NEW ONE AS I HAD INSERTED ONE ON (B)(6) 2021 THAT FAILED, THIS WAS THE SECOND ONE THAT I INSERTED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11412699 ↗
• MalfunctionMar 2, 2021Therapeutic or Diagnostic Output Failure

  INSERTED NEW MEDTRONIC GUARDIAN SENSOR (3) IN THE MORNING AND ABOUT 5 HOURS LATER I HAD TO REPLACE THE SENSOR DUE TO SENSOR FAILURE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11404365 ↗
• MalfunctionJul 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results; Incorrect, Inadequate or Imprecise Result or Readings; Unexpected Therapeutic Results

  INFORMATION RECEIVED BY MEDTRONIC THE USER REPORTED INACCURATE SENSOR READINGS THAT TRIGGERED A THRESHOLD SUSPEND. THE CUSTOMER¿S BLOOD GLUCOSE WAS 89 MG/DL AND SENSOR GLUCOSE WAS 43 MG/DL AT THE TIME OF THE EVENT, THE DIFFERENCE WAS OUTSIDE THE ACCEPTABLE RANGE. SUSPEND ON LOW LIMIT IN SENSOR SETTINGS WAS AT 70 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 10331950 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160007. One submission often covers many models, so check the product and lot details in each record.

• Z-0033-2026 · May 7, 2025 · Open, Classified
  Medtronic, Simplera Sensor, REF: MMT-5100JD1
• Z-2106-2020 · May 20, 2019 · Open, Classified
  Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
• Z-1282-2019 · Jul 4, 2018 · Terminated
  Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.