Home / Recalls / Sorin Group Italia SRL - CRF / Z-3230-2017

Z-3230-2017 Class II Terminated

Recalled by Sorin Group Italia SRL - CRF — Saluggia, VC, N/A

Recall Details

Product Type
Devices
Report Date
October 4, 2017
Initiation Date
July 24, 2017
Termination Date
January 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
154 units

Product Description

Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, 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

Code Information

All Serial Numbers

Other recalls by Sorin Group Italia SRL - CRF

  • Z-3232-2017 Class II — Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantabl (July 24, 2017)
  • Z-3233-2017 Class II — Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable (July 24, 2017)
  • Z-3229-2017 Class II — Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable ca (July 24, 2017)
  • Z-3228-2017 Class II — Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable ca (July 24, 2017)
  • Z-3231-2017 Class II — Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantabl (July 24, 2017)
  • Z-2114-2017 Class II — INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, O (April 11, 2017)
  • Z-2112-2017 Class II — OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, (April 11, 2017)
  • Z-2113-2017 Class II — PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D (April 11, 2017)