CLASS II Device recall · Reported 4 Oct 2017 · FDA Enforcement Report
Platinium DR DF4 recalled by Sorin Group Italia SRL - CRF
Sorin Group Italia SRL - CRF is recalling Platinium DR DF4 1540, distributed nationwide in the US. The recall was initiated on 24 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3232-2017
- FDA event ID
- 77983
- Recalling firm
- Sorin Group Italia SRL - CRF, Saluggia, VC, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2017
- FDA classified
- 27 Sep 2017
- Reported
- 4 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 24 Jul 2017 | Recall initiated by company | |
| 27 Sep 2017 | Classified by FDA | +65 days |
| 4 Oct 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All Serial Numbers
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 77983This product is part of a recall event; the main page for the event is Platinium VR DF4 recalled by Sorin Group Italia SRL - CRF.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Platinium VR DF4 recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide | |
| CLASS II | Platinium Crt-d recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide | |
| CLASS II | Platinium VR recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide | |
| CLASS II | Platinium CRT DF1 recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide | |
| CLASS II | Platinium DR recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide |
More recalls from Sorin Group Italia SRL - CRF
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Platinium DR recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide |
| Device | CLASS II | Platinium CRT DF1 recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide |
| Device | CLASS II | Platinium VR recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide |
| Device | CLASS II | Platinium Crt-d recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide |
| Device | CLASS II | Platinium VR DF4 recalled by Sorin Group Italia SRL - CRF | Sorin Group Italia SRL - CRF | Other | Nationwide |
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