Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D

FDA Device Recall #Z-2173-2014 — Class II — June 16, 2014

Recall Summary

Recall Number Z-2173-2014
Classification Class II — Moderate risk
Date Initiated June 16, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic MiniMed Inc.
Location Northridge, CA
Product Type Devices
Quantity 764 units

Product Description

Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D

Reason for Recall

Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device.

Distribution Pattern

New Jersey and Worldwide: Belgium, France, Netherland, and Sweden

Lot / Code Information

n/a

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-0437-2016 Class II MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 ... 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

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.