MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: in...
FDA Device Recall #Z-0516-2021 — Class II — April 30, 2020
Recall Summary
| Recall Number | Z-0516-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 30, 2020 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc. |
| Location | Northridge, CA |
| Product Type | Devices |
| Quantity | 391 |
Product Description
MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values.
Reason for Recall
Missing solder battery connection, which could interrupt power of insulin pump.
Distribution Pattern
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.
Lot / Code Information
All serial numbers expiration date- 3 years from date of manufacture. NG2093124H NG2093129H NG2093154H NG2093164H NG2093187H NG2093188H NG2093193H NG2093219H NG2093228H NG2093235H NG2093253H NG2093254H NG2093257H NG2093258H NG2093265H NG2093269H NG2093288H NG2093303H NG2093307H NG2093345H NG2093349H NG2093362H NG2093377H NG2093397H NG2093423H NG2093425H NG2093426H NG2093463H NG2093466H NG2093476H NG2093478H NG2093521H NG2093558H NG2093564H NG2093577H NG2093608H NG2093624H NG2093670H NG2093673H NG2093675H NG2093693H NG2093697H NG2093707H NG2093708H NG2093711H NG2093712H NG2093734H NG2093743H NG2093764H NG2093777H NG2093825H NG2093835H NG2093844H NG2093860H NG2093869H NG2093871H NG2093889H NG2093891H NG2093894H NG2093922H NG2093932H NG2093969H NG2093973H NG2093981H NG2094026H NG2094030H NG2094035H NG2094043H NG2094044H NG2094048H NG2094053H NG2094075H NG2094082H NG2094231H NG2094234H NG2094235H NG2094237H NG2094239H NG2094241H NG2094242H NG2094245H NG2094248H NG2094249H NG2094250H NG2094254H NG2094256H NG2094258H NG2094259H NG2094262H NG2094263H NG2094266H NG2094272H NG2094274H NG2094276H NG2094281H NG2094282H NG2094286H NG2094288H NG2094289H NG2094290H NG2094292H NG2094294H NG2094295H NG2094297H NG2094302H NG2094303H NG2094304H NG2094306H NG2094307H NG2094313H NG2094315H NG2094322H NG2094326H NG2094329H NG2094330H NG2094338H NG2094341H NG2094342H NG2094344H NG2094347H NG2094349H NG2094351H NG2094352H NG2094355H NG2094358H NG2094360H NG2094362H NG2094363H NG2094364H NG2094366H NG2094368H NG2094376H NG2094380H NG2094382H NG2094389H NG2094390H NG2094393H NG2094398H NG2094401H NG2094402H NG2094403H NG2094406H NG2094408H NG2094419H NG2094424H NG2094428H NG2094430H NG2094433H NG2094434H NG2094444H NG2094447H NG2094450H NG2094454H NG2094458H NG2094460H NG2094461H NG2094464H NG2094466H NG2094470H NG2094471H NG2094477H NG2094479H NG2094485H NG2094489H NG2094490H NG2094493H NG2094496H NG2094497H NG2094499H NG2094509H NG2094517H NG2094519H NG2094527H NG2094528H NG2094529H NG2094533H NG2094534H NG2094536H NG2094537H NG2094555H NG2094585H NG2094594H NG2111643H -U.S.
Other Recalls from Medtronic Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3152-2024 | Class II | 2090 Programmers with serial number prefixes PK... | Jul 11, 2024 |
| Z-2197-2024 | Class II | EVERA MRI S VR SureScan, Model Number DVMC3D4, ... | Apr 16, 2024 |
| Z-2206-2024 | Class II | COBALT DR MRI SureScan, Model Number DDPB3D1, I... | Apr 16, 2024 |
| Z-2190-2024 | Class II | COBALT HF QUAD CRT-D MRI SureScan, Model Number... | Apr 16, 2024 |
| Z-2210-2024 | Class II | COBALT XT VR MRI SureScan, Model Number DVPA2D1... | Apr 16, 2024 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.