Home › Device types › OZO
Automated Insulin Dosing , Threshold Suspend
FDA product code OZO · Class 3 · Unknown
275
Registered devices
439,398
Adverse events
11
Recalls
0
510(k) clearances
Devices with this code
MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.Medtronic Guardian™ Link — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.CONTOUR® NEXT — ASCENSIA DIABETES CARE US INC.Guardian ™ Sensor (3) — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 630G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.Enlite® Serter — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.CONTOUR®NEXT — ASCENSIA DIABETES CARE US INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 630G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.MiniMed® 530G — MEDTRONIC MINIMED, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-13 | Medtronic MiniMed, Inc. | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insul |
| 2026-02-13 | Medtronic MiniMed, Inc. | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insul |
| 2025-01-31 | Medtronic MiniMed, Inc. | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to ch |
| 2024-07-31 | Medtronic MiniMed, Inc. | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump bat |
| 2022-05-23 | Medtronic MiniMed | Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power |
| 2020-04-30 | Medtronic Inc. | Missing solder battery connection, which could interrupt power of insulin pump. |
| 2019-11-21 | Medtronic Inc. | There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing re |
| 2018-10-03 | Medtronic Inc. | Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could c |
| 2017-10-10 | Medtronic Inc. | Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result |
| 2017-05-08 | Medtronic Inc. | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. |
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