Class 2 Device Recall

• Date Initiated by Firm: August 29, 2003
• Date Posted: November 27, 2003
• Recall Status: Terminated on September 02, 2005
• Recall Number: Z-0168-04
• Recall Event ID: 27474
• 510(K)Number: K001829
• Product Classification: Pump, Infusion, Insulin - Product Code LZG
• Product: Paradigm Model 511 and 512 Insulin Infusion Pumps
• Code Information: Codes are irrelevant
• Recalling Firm/ Manufacturer: Medtronic MiniMed; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: Mark J. Faillace; 818-576-5616
• Manufacturer Reason for Recall: Water ingresses into the device when in prolonged contact with water causing device to malfunction.
• FDA Determined Cause: Other
• Action: The firm sent notifications to all pump users of record, all distributors and all certified pump trainers indications that the pumps should not be immersed in water. Canadian users were contacted by Medtronic Canada.
• Quantity in Commerce: Approximately 61,000 patients
• Distribution: Nationwide and Canada
• 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