Simplera Sync™ MMT-5120A

• FDA PMA P160017 decided 28 Sep 2016 Active
• FDA GUDID UDI-DI 20763000956381 listed 1 Jun 2025 Listed

• • Ongoing Z-2981-2026 FDA Class II ·initiated 13 Jul 2026

  Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.

• 2 recalls, same reason

  • Ongoing Z-1742-2026 FDA Class II ·initiated 13 Feb 2026
  • Ongoing Z-1739-2026 FDA Class II ·initiated 13 Feb 2026

  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.

• 3 recalls, same reason

  • Ongoing Z-1261-2025 FDA Class II ·initiated 31 Jan 2025
  • Ongoing Z-1266-2025 FDA Class II ·initiated 31 Jan 2025
  • Ongoing Z-1265-2025 FDA Class II ·initiated 31 Jan 2025

  All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

• • Ongoing Z-0003-2025 FDA Class I ·initiated 31 Jul 2024

  Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.

• • Ongoing Z-0193-2023 FDA Class II ·initiated 20 Sep 2022

  Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.

• • Ongoing Z-0855-2022 FDA Class II ·initiated 27 Jan 2022

  New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.

• • Ongoing Z-1771-2021 FDA Class II ·initiated 15 Mar 2021

  Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery.

• • Ongoing Z-0516-2021 FDA Class II ·initiated 30 Apr 2020

  Missing solder battery connection, which could interrupt power of insulin pump.

• • Ongoing Z-0956-2020 FDA Class I ·initiated 21 Nov 2019

  There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.

• 2 recalls, same reason

  • Terminated Z-2604-2017 FDA Class II ·initiated 8 May 2017
  • Terminated Z-2605-2017 FDA Class II ·initiated 8 May 2017

  Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.

1. 27 Jan 2022 Recall initiated FDA recalls Z-0855-2022
2. 20 Sep 2022 Recall initiated FDA recalls Z-0193-2023
3. 31 Jul 2024 Recall initiated FDA recalls Z-0003-2025
4. 31 Jan 2025 Recall initiated FDA recalls Z-1261-2025
5. 31 Jan 2025 Recall initiated FDA recalls Z-1266-2025
6. 31 Jan 2025 Recall initiated FDA recalls Z-1265-2025
7. 1 Jun 2025 Listed FDA GUDID 20763000956381
8. 13 Feb 2026 Recall initiated FDA recalls Z-1742-2026
9. 13 Feb 2026 Recall initiated FDA recalls Z-1739-2026
10. 13 Jul 2026 Recall initiated FDA recalls Z-2981-2026

6 earlier events are in the sections above.

Trade name

Simplera Sync™

Generic name

Percutaneous interstitial fluid glucose monitoring system, electrochemical

Model / reference

MMT-5120A

Primary DI / UDI-DI

20763000956381

PMA number

P160017 ↗

FDA product code

OZP

GMDN term

Percutaneous interstitial fluid glucose monitoring system, electrochemical

Device class

Class III

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Percutaneous interstitial fluid glucose monitoring system, electrochemical

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