Skip to content

Animas Vibe System

by Animas Corp. PMA

Withdrawn United States

PMA P130007

Overview

The Animas Vibe System is an insulin pump designed for continuous subcutaneous insulin infusion to manage insulin-requiring diabetes. It integrates with the Dexcom G4 Platinum sensor and transmitter to receive and display continuous glucose measurements, aiding in the detection of hyperglycemia and hypoglycemia trends.

This device is intended for single-patient use and requires a prescription for operation. It is designed to complement standard home glucose monitoring devices rather than replace them, with glucose monitoring indications specifically for adults aged 18 and older. The system has received FDA PMA approval for its clinical application.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

Withdrawn since 25 Nov 2014. The authorization below is no longer in force.

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP130007 Date25 Nov 2014Approval withdrawnStatusWithdrawn

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Withdrawn

Recalls

1 recall · FDA

    • Terminated Z-1034-2015 FDA Class II initiated 6 Sep 2011

    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.

Specification

PMA

Generic Name
Pump, infusion, insulin, to be used with invasive glucose sensor
PMA Number
FDA Product Code
OYC
Device Class
Class III
Advisory Committee
Clinical Chemistry
FDA Decision
APWD Approval withdrawn

Other devices from Animas Corp.

See all devices from Animas Corp. →

Questions

  • What is the primary function of the Animas Vibe System?

    The system functions as an insulin pump for continuous subcutaneous insulin infusion and as a continuous glucose monitoring system that displays data from the Dexcom G4 Platinum sensor.

  • Can the Animas Vibe System replace standard home glucose monitoring?

    No, the system is intended to complement, not replace, information obtained from standard home glucose monitoring devices, as interpretation should be based on trends over time.

  • Who is the intended user for this device?

    The system is indicated for single-patient use by individuals aged 18 and older who require insulin for the management of diabetes.