Platinium CRT-D 1741 — Class II medical device recall Z-3233-2017
Terminated recall by Sorin Group Italia SRL - CRF, reported 2017-10-04, distributed nationwide. There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and C
| Recall number | Z-3233-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group Italia SRL - CRF, Saluggia, VC, N/A, Italy |
| Recall initiated | 2017-07-24 |
| Classified | 2017-09-27 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2024-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 68 units |
| UPC / GTIN / UDI-DI | 08031527015484 |
| Model numbers | TDF037U |
Product
Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3233-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.