Recall Z-0178-2020— Medtronic Inc.
Class I · Terminated
Class I FDA medical device recall by Medtronic Inc., initiated 2018-08-07, terminated 2024-03-29. It names 2 FDA 510(k) clearances: K120206, K001829. Product: 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). Reason: There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps..
- Recalling firm
- Medtronic Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-08-07
- Terminated
- 2024-03-29
- Firm location
- Northridge, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K120206 — MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
- K001829 — MINIMED PARADIGM INSULIN PUMP, MODEL 511
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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)
Reason for recall
There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
Data sourced from openFDA. This site is unofficial and independent of the FDA.