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U.S. Department of Health and Human Services

Class 1 Device Recall MMT500

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  Class 1 Device Recall MMT500 see related information
Date Initiated by Firm August 07, 2018
Date Posted November 04, 2019
Recall Status1 Open3, Classified
Recall Number Z-0177-2020
Recall Event ID 82078
510(K)Number K990801  
Product Classification Pump, infusion, insulin - Product Code LZG
Product Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
Code Information All serial numbers
Recalling Firm/
Manufacturer
Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Pamela Reese
818-576-3398
Manufacturer Reason
for Recall
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
FDA Determined
Cause 2
Software design
Action Medtronic sent an Urgent Field Safety Notification letter dated August 7, 2018 to the patient, distributor, and healthcare provider via email, U.S. mail, or phone. The letter identified the affected product, problem and actions to be taken. On 10/05/2021, recall notices were sent to patients, health care professionals, distributors, and personnel at clinical sites. Distributors were asked to provide their customer lists to the recalling firm so the recalling firm could send customers recall notices. The scope of the recall is being expanded to all users regardless of warranty status. Users are asked to stop using and disconnect the remote controller, disable the remote feature, and return the remote controller to the recalling firm. Customers were also asked to provide the information requested in the confirmation form to the recalling firm via phone, mail, email, or online on the firm's website. Additional questions can be directed to Technical Support at 1-800-378-2292. Disconnecting/Disabling instructions were provided in the recall notice, which provided the following link: https://info.medtronicdiabetes.com/remote-controller-return
Quantity in Commerce 90,213
Distribution Distribution was nationwide to consumers and distributors. There was no government/military distribution. Foreign distribution was made to Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Martinique, Namibia, Netherlands, New Caledonia, Norway, Oman, Pakistan, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, and United Kingdom.
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 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) Database 510(K)s with Product Code = LZG and Original Applicant = MEDTRONIC MINIMED
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