Minimed Paradigm Insulin Pump, Model 511

• • Terminated Z-0178-2020 FDA Class I ·initiated 7 Aug 2018 ·on shared 510(k) K001829

  There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.

• • Terminated Z-1007-2007 FDA Unclassified (pre-2012) ·initiated 27 Apr 2007 ·on shared 510(k) K001829

  Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi

• • Terminated Z-0168-04 FDA Unclassified (pre-2012) ·initiated 29 Aug 2003 ·on shared 510(k) K001829

  Water ingresses into the device when in prolonged contact with water causing device to malfunction.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K001829 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K030531 Active Cleared 17 Jun 2003

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  Class II

  FDA 510(k) K031541 Active Cleared 18 Nov 2003

See all devices from Minimed, Inc. →