The Recall Desk
HighFDA (Devices)·Z-1772-2021·Announced 2021-06-09

MiniMed 670G Insulin Pump Software Flaw Risks Insulin Overdose

A software design issue in the MiniMed 670G insulin pump may cause insulin overdose when users are unaware of active insulin levels. Medtronic is recalling clinical study devices.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall involves a risk-of-harm medical device where insulin overdose is possible, but no illnesses or injuries have been reported. The FDA's Class II classification and absence of adverse event reports place this at Score 3 per the rubric for risk-of-harm products without reported injury.

Plain-English summary

The MiniMed 670G insulin pump from Medtronic contains a software design issue that can trigger a fault when a large bolus is delivered at quick speed. If users are unaware of their active insulin level and deliver an additional bolus, an insulin overdose may occur.

The recall affects investigational devices from Medtronic's clinical study program. Approximately 1,266 pump units were distributed across the United States and several other countries as part of the clinical study.

Patients enrolled in the clinical study should contact their study coordinator or Medtronic for guidance on their specific device and next steps. If insulin overdose is suspected, seek immediate medical attention. Users should verify active insulin information before administering additional bolus doses.

The recalled product

Product
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 0
Manufacturer
Medtronic Minimed
Category
Medical Device — Insulin Pump
Hazard
  • insulin-overdose
  • software-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model #(CFN)/¿UDI-DI(GTIN): MMT-1740K/00763000258429
  • ¿ MMT-1740KX/00763000408909
  • ¿ MMT-1741KFX/00763000303556
  • ¿ MMT-1741KFX/00763000408930
  • ¿ MMT-1741KX/00763000258436
  • ¿ MMT-1741KX/00763000408916
  • ¿ MMT-1741KXS/00763000258443
  • ¿ MMT-1741KXS/00763000408923
  • ¿ MMT-1742KX/00763000157456
  • ¿ MMT-1742KX/00763000250232
  • ¿ MMT-1742KX/00763000258467
  • ¿ MMT-1742KX/00763000408954
  • ¿ MMT-1742KX/00763000408947
  • Serial Numbers: NG1522406H
  • NG1698348H
  • NG2078422H
  • NG1586805H
  • NG1997312H
  • NG1829832H
  • NG1662936H

Distribution

Distributed in 12 states:

  • AR
  • CA
  • CO
  • CT
  • FL
  • GA
  • ID
  • MI
  • MN
  • TN
  • TX
  • WA

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