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U.S. Department of Health and Human Services

Class 2 Device Recall Paradigm Insulin Pump System

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 Class 2 Device Recall Paradigm Insulin Pump Systemsee related information
Date Initiated by FirmJune 27, 2019
Date PostedMarch 26, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1583-2020
Recall Event ID 83433
510(K)NumberK120206 
Product Classification Pump, infusion, insulin - Product Code LZG
ProductMiniMed Paradigm 512 Insulin pump
Code Information All Software Versions
Recalling Firm/
Manufacturer		 Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information ContactMedtronic 24-hr Technical Support
818-576-4700
Manufacturer Reason
for Recall		The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.
FDA Determined
Cause 2		Device Design
ActionOn June 27, 2019, Medtronic issued an Urgent Field Safety Notification letter via mail and email to its consignees. Medtronic made the decision to renotify customers, and on January 4, 2023, Medtronic issued an Urgent Medical Device Correction - Update letter. The communication asks consignees to take the following actions: .To find the software version for the MiniMed Paradigm pumps, go to the STATUS screen: . To open the STATUS screen, press ESC until the STATUS screen appears. . To view more text on the STATUS screen, press the up or down arrow to scroll and view all the information. . To exit the STATUS screen, press ESC until the STATUS screen disappears. ACTIONS REQUIRED: 1. Review and take the following cybersecurity precautions listed below. 2. Please complete and sign the customer confirmation form attached as indicated and return by mail using the attached prepaid envelope. You can also email this form to our Field Corrective Action Department at rs.safetyinformation@medtronic.com or send via fax to 1-888-844-8084 to the attention of FCA Department.
Quantity in Commerce34,777
DistributionUS nationwide distribution including Puerto Rico.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LZG
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