Z-3232-2017Class II

Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator...

Name: Z-3232-2017 Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator...
Creator: Sorin Group Italia SRL - CRF
Published: 2017-07-24
License: https://open.fda.gov/license/

Corcym Inc. / initiated 2017-07-24 / Terminated / root cause: software

FDA source

Sorin Group Italia SRL - CRF began a recall of Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia... on 2017-07-24. FDA classified it as Class II and gives the reason as "There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-3232-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Posted: 2017-09-28
Terminated: 2024-01-29
Recalling firm: Corcym Inc.
Product: Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, 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).
Product code: MRM Defibrillator, Implantable, Dual-Chamber
Reason for recall: There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.
Root cause tag: software
FDA root cause: Software design
Action: LivaNova issued a communication to physicians treating patients implanted with the products in scope in the form of a customer letter beginning July 24, 2017. The letter instructs users to do the following: 1. In order to mitigate the potential risks associated with both triggering events (ESD at implant or MRI scan), LivaNova recommends physicians follow the patients at the periodicity already stated in the implant manual, especially: " Before the patient is discharged and at each subsequent follow-up, it is advisable to check the battery status and the occurrence of system warnings; " It is recommended that a routine follow-up examination be done one month after discharge, and then every three months until the device nears the replacement date.
Quantity in commerce: 86 units
Distribution: US Nationwide Distribution
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3232-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3228-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3229-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3230-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3231-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3232-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27
Z-3233-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27

Product code MRM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)