Medtronic MiniMed 630G 6025805-003_C — Class II medical device recall Z-0683-2019
Ongoing recall by Medtronic Inc., reported 2019-01-02, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio so
| Recall number | Z-0683-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Northridge, CA, United States |
| Recall initiated | 2018-10-03 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Quantity | 142,889 |
| Reason classes | software |
| Serial numbers | NG1329859H, NG1330099H, NG1330107H, NG1330110H, NG1330113H, NG1330122H, NG1330133H, NG1330136H, NG1330140H, NG1330142H, NG1330143H, NG1330145H, NG1330154H, NG1330160H, NG1343242H, NG1343243H, NG1343244H, NG1343245H, NG1343246H, NG1343248H, NG1343249H, NG1343250H, NG1343252H, NG1343253H, NG1343254H and 475 more |
Product
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Reason for recall
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 cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0683-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.