Z-1034-2015Class II

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin...

Name: Z-1034-2015 Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin...
Creator: Animas Corporation
Published: 2011-09-06
License: https://open.fda.gov/license/

Animas Corp. / initiated 2011-09-06 / Terminated / root cause: software

FDA source

Animas Corporation began a recall of Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous... on 2011-09-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1034-2015
Classification: Class II
Status: Terminated
Initiated: 2011-09-06
Posted: 2015-01-30
Terminated: 2015-08-10
Recalling firm: Animas Corp.
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.
Product code: OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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.
Root cause tag: software
FDA 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 in commerce: 1235
Distribution: No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1034-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1034-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-01-30

Product code OYC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)