Class 2 Device Recall Animas Vibe Insulin Infusion Pump

• Date Initiated by Firm: September 06, 2011
• Date Posted: January 30, 2015
• Recall Status: Terminated on August 10, 2015
• Recall Number: Z-1034-2015
• Recall Event ID: 69299
• PMA Number: P130007
• Product Classification: Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
• Product: 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.
• Code Information: Model Number(s): 100515-63 100510-63 100514-63 100512-63 100511-63 101200-03 100201-03 101202-03 101204-03 101205-03 101200-53 101202-53 101205-53 101200-02 101200-57 101201-57 101202-57 101204-57 101205-57 101200-63 101201-63 101202-63 101204-63 101205-63 101206-63
• FEI Number: 3002920072
• Recalling Firm/ Manufacturer: Animas Corporation; 200 Lawrence Dr; West Chester PA 19380-3428
• For Additional Information Contact: Customer Support; 610-644-8900
• Manufacturer 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.
• FDA Determined Cause: Software design (manufacturing process)
• Action: 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.
• Quantity in Commerce: 1235
• Distribution: No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = OYC