Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infus...
FDA Recall #Z-1034-2015 — Class II — September 6, 2011
Product Description
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.
Reason for Recall
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.
Recalling Firm
Animas Corporation — West Chester, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1235
Distribution
No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
Code Information
Model Number(s): 100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03 101205-03 101200-53 101202-53 101205-53 101200-02 101200-57 101201-57 101202-57 101204-57 101205-57 101200-63 101201-63 101202-63 101204-63 101205-63 101206-63
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated