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Recall Observatory FDA recall evidence

Device product

MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.

Z-2260-2015

June 19, 2015

Class II

Product summary

Firm
Medtronic MiniMed Inc.
Event
Event 70897
Status
Terminated
Classification
Class II
Quantity
1936 units
Official record key
device-enforcement:Z-2260-2015

Official wording

Reason: Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.

Code information: n/a

Distribution pattern: Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate.