Recall Z-0178-2020 ยท LZG Pump, Infusion, Insulin
Medtronic Inc.
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)
| Date | Nov 4, 2019 (initiated Aug 7, 2018) |
| Status | Terminated |
| Reason | There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. |
| Root cause | 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. 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 |
| Quantity | 141,519 |
| 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, Hung |
| FDA record | Open on fda.gov |