Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Animas Vibe Insulin Infusion Pump. This product is indicated for Recalled by Animas Corporation Due to Calibration factors in the pump overwritten during a...

Date: September 6, 2011
Company: Animas Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Animas Corporation directly.

Affected Products

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.

Quantity: 1235

Why Was This Recalled?

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.

Where Was This Sold?

No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.

About Animas Corporation

Animas Corporation has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report