Recall Z-0517-2021 ยท OZO Automated Insulin Dosing , Threshold Suspend
Medtronic Inc.
MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, fourteen years of age and older, requiring insulin.
| Date | Apr 30, 2020 |
| Status | Open, Classified |
| Reason | Missing solder battery connection, which could interrupt power of insulin pump. |
| Root cause | Nonconforming Material/Component |
| Action | On April 30, 2020, the firm mailed a "Urgent Medical Device Recall" letter to patients. The firm also sent a letter to Health Care Professionals, (HCP) "Urgent Medical Device Recall" that they read this notice and confirm receipt that the customer read and understood the instructions provided in this letter. The letter notified customers that the insulin pumps had an issue on the battery connection that did not meet firm's quality specifications. If power is interrupted on a patients insulin pump, then insulin is suspended, which may lead to hyperglycemia (high blood sugar). There have been no |
| Quantity | 206 |
| Distribution | Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.