MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump s...
FDA Device Recall #Z-0437-2016 — Class II — September 25, 2015
Recall Summary
| Recall Number | Z-0437-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 25, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic MiniMed Inc. |
| Location | Northridge, CA |
| Product Type | Devices |
| Quantity | 53 units |
Product Description
MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
Reason for Recall
The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
Distribution Pattern
Internationally Distribution only to the countries of : Australia, Austria, Belgium, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Japan, Kenya, Luxembourg, Namibia, Netherlands, Norway, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom.
Lot / Code Information
NG1019903H NG1019906H NG1019907H NG1019909H NG1019914H NG1019915H NG1019916H NG1019918H NG1019921H NG1019922H NG1019923H NG1019925H NG1019926H NG1019928H NG1019930H NG1019931H NG1019932H NG1019933H NG1019935H NG1019937H NG1019939H NG1019940H NG1019943H NG1019944H NG1019946H NG1019949H NG1019950H NG1019953H NG1019966H NG1019971H NG1019975H NG1019976H NG1019979H NG1019981H NG1019989H NG1019997H NG1019999H NG1020001H NG1020006H NG1020007H NG1020012H NG1020015H NG1020017H NG1020018H NG1020019H NG1020020H NG1020022H NG1020023H NG1020026H NG1020027H NG1020028H NG1020029H NG1020031H
Other Recalls from Medtronic MiniMed Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1501-2016 | Class II | CareLink iPro2 Reports, Model No. MMT-7340 is ... | Feb 19, 2016 |
| Z-0438-2016 | Class II | MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model ... | Sep 25, 2015 |
| Z-2442-2015 | Class II | Guardian Real-Time Monitor, Model No. CSS7100. ... | Jul 22, 2015 |
| Z-2260-2015 | Class II | MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-... | Jun 19, 2015 |
| Z-1228-2015 | Class III | CareLink Pro Medtronic CareLink Pro MMT-7335 i... | Nov 10, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.