RECALL OF PRODUCT -
Medtronic
MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models:
MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722, Recall #
Z-1007-2007.
All serial numbers for the following Paradigm models: MMT-511,
MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722 . RECALLING
FIRM/MANUFACTURER - Medtronic MiniMed, Northridge, CA, by letters on
April 24, 2007. Firm initiated recall is ongoing.
REASON -
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 hypoglycemia.
Animas Corporation 200 Lawrence Drive West Chester, PA 19380
1-877-YES-PUMP (1-877-937-7867)
Customer Service: 1-877-767-7373
Outside US: 1-610-644-8990
Manufactures and sells the IR 2020, IR 2000, IR 1250, IR 1200, IR 1000 and sells refurbished older pumps.
While the features have been enhanced with each model, the overall outward appearance has not changed much since the redesign that began with thet IR 1200.
In July of 2005 the FDA wrote a warning to DANA Diabecare that it had improperly reported pump problems that had caused serious harm to some of their users.
The ACCU-CHEK Spirit, H-TRONplus, and D-TRONplus are marketing by Disetronic Medical Systems USA.
ACCU-CHEK Spirit
DTRONplus Insulin Pump
HTRONplus Insulin Pump
Smiths Medical MD, Inc. – Manufactures the Deltec Cozmo® insulin pump. The CozMore Pump comes with an attachable glucose meter that interacts with the pump (this is not the same thing as continuous glucose monitoring).
Recent software and feature upgrades (2006) were added to this pump which is sold in three different colors.
