Platinium VR DF4 1240 ICD Recall: Risk of Overconsumption After ESD or MRI
Sorin Group recalls Platinium VR DF4 1240 ICDs with model TDF035U due to potential overconsumption after electrostatic discharge during surgery or MRI scans. Affected patients should contact manufacturer for guidance.
Recall notice
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.
Contact the company
What happened, in plain English
Sorin Group is recalling Platinium VR DF4 1240 implantable cardioverter defibrillators (ICDs) with model number TDF035U. The recall is due to a potential risk of overconsumption following electrostatic discharge during surgery or MRI scans. This could affect patients with specific heart conditions who require these devices. Read more at govinfonow.com/recall/73363-platinium-vr-df4-1240-icd-recall-risk-of-overconsumption-after.
Source Summary by GovInfoNow · govinfonow.com/recall/73363-platinium-vr-df4-1240-icd-recall-risk-of-overconsumption-after · Updated September 20, 2026 · FDA enforcement record: FDA #Z-3231-2017
Cite this page
“Platinium VR DF4 1240 ICD Recall: Risk of Overconsumption After ESD or MRI.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73363-platinium-vr-df4-1240-icd-recall-risk-of-overconsumption-after. Based on FDA recall #Z-3231-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3231-2017%22&limit=1).
Why it’s dangerous
The device may overconsume during electrostatic discharge events that occur during implant surgery or MRI scans. This could lead to improper device function or failure in patients who rely on the device for life-saving cardiac monitoring.
Who’s affected
Patients with biventricular or ventricular antitachycardia pacing who require an implantable cardioverter defibrillator (ICD) for high-risk cardiac conditions. Those who have undergone surgery or MRI scans with the affected device are most at risk.
How to tell if you have this one
Check for the model number TDF035U on the device. The product was sold with serial numbers starting with 08031527015460. Affected devices are used for patients at high risk of sudden cardiac death due to ventricular tachyarrhythmias.
- Brand
Sorin Group- Product
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide Distribution
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3228-2017 | 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).; All Serial Numbers | 125 units |
| Z-3229-2017 | Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, 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).; All Serial Numbers | 206 units |
| Z-3230-2017 | 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).; All Serial Numbers | 154 units |
| Z-3231-2017 | Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, 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).; All Serial Numbers | 72 units |
| Z-3232-2017 | 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).; All Serial Numbers | 86 units |
| Z-3233-2017 | 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).; All Serial Numbers | 68 units |
What to do — step by step
Contact Manufacturer
Reach out to Sorin Group for specific guidance on device safety and next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 6.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3231-2017 (July 24, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3231-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.