FDASeptember 6, 2011device
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.
What to do
FDA enforcement status: Terminated
Brands named
animas
Recall history
No related federal recalls on record for this brand yet.
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