Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibr...
FDA Device Recall #Z-3228-2017 — Class II — July 24, 2017
Recall Summary
| Recall Number | Z-3228-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 24, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sorin Group Italia SRL - CRF |
| Location | Saluggia, VC, N/A |
| Product Type | Devices |
| Quantity | 125 units |
Product Description
Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
Reason for Recall
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
All Serial Numbers
Other Recalls from Sorin Group Italia SRL - CRF
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3231-2017 | Class II | Platinium VR DF4 1240, Model Number TDF035U, UD... | Jul 24, 2017 |
| Z-3233-2017 | Class II | Platinium CRT-D 1741, Model Number TDF037U, UDI... | Jul 24, 2017 |
| Z-3232-2017 | Class II | Platinium DR DF4 1540, Model Number TDF036U, UD... | Jul 24, 2017 |
| Z-3230-2017 | Class II | Platinium CRT DF1 1711, Model Number TDF033U, U... | Jul 24, 2017 |
| Z-3229-2017 | Class II | Platinium DR 1510, Model Number TDF032U, UDI/GT... | Jul 24, 2017 |
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.