Recall Z-0001-2025 ยท OZO Automated Insulin Dosing , Threshold Suspend
Medtronic MiniMed, Inc.
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
| Date | Oct 3, 2024 (initiated Jul 31, 2024) |
| Status | Open, Classified |
| Reason | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stoppi |
| Root cause | Device Design |
| Action | On 7/31/24, Safety Alert notices were sent to customers, healthcare professionals, distributors who were told the following: 1) Always pay attention to alerts and alarms displayed on your pump. - Low Battery Pump alert will display when your pump has up to 10 hours of battery life left. - Replace Battery alert will display when the pump has less than 30 minutes of battery life left. If the battery is not replaced within 10 minutes, a siren will sound and repeat once every minute until the Replace Battery Now alarm is displayed. At that time, the pump will stop insulin delivery. If the battery |
| Quantity | 24,595 |
| Distribution | US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR. OUS: Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.