Animas Vibe Insulin Infusion Pump — Class II medical device recall Z-1034-2015
Terminated recall by Animas Corporation, reported 2015-02-11. Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower sig
| Recall number | Z-1034-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Animas Corporation, West Chester, PA, United States |
| Recall initiated | 2011-09-06 |
| Classified | 2015-01-30 |
| Reported by FDA | 2015-02-11 |
| Terminated | 2015-08-10 |
| Countries outside the US | DE, FR, GB, SE |
| Quantity | 1,235 |
| Reason classes | device malfunction |
| Model numbers | 100201-03, 100510-63, 100511-63, 100512-63, 100514-63, 100515-63, 101200-02, 101200-03, 101200-53, 101200-57, 101200-63, 101201-57, 101201-63, 101202-03, 101202-53, 101202-57, 101202-63, 101204-03, 101204-57, 101204-63, 101205-03, 101205-53, 101205-57, 101205-63, 101206-63 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1034-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.