FDA Medical Device Recalls (openFDA)
Animas Corporation: 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.
- Recall number
- Z-1034-2015
- Recalling firm
- Animas Corporation
- 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.
- Status
- Terminated
- Initiated
- 2011-09-06
- Posted
- 2015-01-30
- Terminated
- 2015-08-10
- 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.
- Root cause
- Software design (manufacturing process)
- Action
- The field action was initiated on 8/29/2011 and comprised communication to patients and distributors using email, letters and verbal communication. In addition, notifications were sent to those Health Care Professionals who had patients that were affected by this field action. Health Authorities were notified in those countries where the pump had been distributed (France, Germany, Sweden and United Kingdom) or was in the hands of patients. Replacement product was provided to distributors and end users who were identified as having affected product.
- Quantity
- 1235
- Distribution
- No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P130007"]
- Product code
- OYC
- Firm FEI
- 3002920072
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28