FDA Device recall Z-1034-2015
Animas Vibe Insulin Infusion Pump
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of Animas Vibe Insulin Infusion Pump by Animas, citing 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, occlusi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1034-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-06 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Animas |
| Distribution | n/a |
Product
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
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.
Identifiers
| code_info | Model Number(s): 100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1034-2015%22
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