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

FDA device recall Z-1034-2015 · posted 2015-01-30 · Terminated

Recall details

Recalling firm

Animas Corporation

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.

Action taken

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.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

OYC

Quantity affected

1235

Distribution

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

Date initiated

2011-09-06

Date posted

2015-01-30

Date terminated

2015-08-10

Location

West Chester, PA