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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 29, 2003
Date Posted November 27, 2003
Recall Status1 Terminated 3 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/
Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Mark J. Faillace
Manufacturer Reason
for Recall
Water ingresses into the device when in prolonged contact with water causing device to malfunction.
FDA Determined
Cause 2
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 and Original Applicant = MINIMED, INC.