Class 3 Device Recall MiniMed Model 712 Insulin Infusion Pumps

• Date Initiated by Firm: September 14, 2004
• Create Date: June 25, 2015
• Recall Status: Terminated on March 03, 2005
• Recall Number: Z-0010-05
• Recall Event ID: 30059
• 510(K)Number: K030531
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: Medtronic MiniMed Paradigm Model 712
• Code Information: Paradigm model 712pumps with serial numbers that end in '-Dxx3' . Where 'x' can be any number or letter.
• Recalling Firm/ Manufacturer: Medtronic MiniMed; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: 800-646-4633
• Manufacturer Reason for Recall: Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
• FDA Determined Cause: Other
• Quantity in Commerce: 10,600
• Distribution: Nationwide & Spain
• 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.

• 510(K) Database: 510(K)s with Product Code = LZG and Original Applicant = MINIMED, INC.