Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insul

FDA device recall Z-0137-2015 · posted 2014-10-24 · Terminated

Recall details

Recalling firm

Animas Corporation

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.

Action taken

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

Status

Terminated

Product code

LZG

Quantity affected

1938

Distribution

Worldwide Distribution in the countries of France, Italy, Sweden, and UK..

Date initiated

2012-10-25

Date posted

2014-10-24

Date terminated

2015-06-29

Location

West Chester, PA