Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)
This recall has been terminated (originally issued November 4, 2019).
- Company
- Medtronic Inc.
- Recall Initiated
- August 7, 2018
- Posted
- November 4, 2019
- Terminated
- March 29, 2024
- Recall Number
- Z-0178-2020
- Quantity
- 141,519
- Firm Location
- Northridge, CA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
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.
Lot / Code Info
All serial numbers
Root Cause
Software design
Action Taken
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. Starting 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