Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA...
FDA Device Recall #Z-1615-2021 — Class II — February 26, 2021
Recall Summary
| Recall Number | Z-1615-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 26, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc. |
| Location | Northridge, CA |
| Product Type | Devices |
| Quantity | 12,624 units |
Product Description
Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.
Reason for Recall
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
All Lot numbers within active shelf life
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 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.