Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Recall Z-0137-2015 · Posted 2014-10-24
Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2012-10-25
Date Terminated2015-06-29
Product Quantity1938
Reason for Recall
Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.
Firm Action
Animas initiated the notification to Distributors by letter, dated July 2012, and Patients and Health Care Professionals were notified by letter in September 2012. The delay in notifying patients and health care professionals was driven by the need to have sufficient inventory of replacement product on hand in order to meet anticipated demand before sending the letters.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution in the countries of France, Italy, Sweden, and UK..
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.