CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates se...
FDA Device Recall #Z-1501-2016 — Class II — February 19, 2016
Recall Summary
| Recall Number | Z-1501-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 19, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic MiniMed Inc. |
| Location | Northridge, CA |
| Product Type | Devices |
| Quantity | 20 |
Product Description
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Reason for Recall
Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
Distribution Pattern
US: MN
Lot / Code Information
n/a
Other Recalls from Medtronic MiniMed Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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 |
| 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.