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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and MiniMed 530G System

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  Class 2 Device Recall Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and MiniMed 530G System see related information
Date Initiated by Firm March 13, 2014
Date Posted August 22, 2014
Recall Status1 Terminated 3 on April 07, 2015
Recall Number Z-2544-2014
Recall Event ID 68277
PMA Number P980022 P120010 
Product Classification Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
Product Medtronic MiniMed Paradigm Insulin Infusion Pumps,

Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754.

MiniMed 530G: MMT-551, and MMT-751

Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
Code Information Paradigm: MMT-523NAB, MMT-723KNB, MMT-523NAH, MMT-723KNH, MMT -523NAL, MMT-723KNL, MMT-523NAP, MMT-723KNP, MMT-523NAS, MMT-723KNS, MMT-723NAB, MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH, MMT-523KNL, MMT-523KNP, MMT-523KNS.  MiniMed 530G: MMT-551NAM, MMT-551NAH, MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL, MMT-751NAP, MMT-751NAS.
Recalling Firm/
Manufacturer		 Medtronic MiniMed Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact
818-567-4700
Manufacturer Reason
for Recall		 Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.
FDA Determined
Cause 2		 Device Design
Action The firm, Medtronic, sent an "IMPORTANT MEDICAL DEVICE SAFETY INFORMATION" letter dated March 13, 2014 to its customers. The letter described the product, problem and actions to be taken. The letter informs the customers that because accidental button pressing errors may occur it is important that customers always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. The letter informs the customers of what safety settings will minimize the risk of an accidental programming error and what actions to be taken. Should you have any questions about this letter or concerns with your keypad, please do not hesitate to contact the 24 hour helpline at (866) 222-7304 for a replacement.
Quantity in Commerce 559,374 units total (444,374 units in US)
Distribution Worldwide Distribution-Nationwide in US
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.
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