Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a significant injury risk (overconsumption of an implanted cardiac device) without reported fatalities, meeting the criteria for a Severe rating.
Plain-English summary
Sorin Group Italia SRL is recalling 125 units of the Platinium VR 1210 implantable cardioverter defibrillator (ICD). The recall involves Model Number TDF031U, UDI/GTIN 08031527015514, and includes all serial numbers. The devices were distributed nationwide in the United States.
The recall is issued because there is a possibility of overconsumption of the device's battery or energy following an ElectroStatic Discharge (ESD) during implant surgery or a Magnetic Resonance Imaging (MRI) scan. The Platinium VR is indicated for patients at high risk of sudden cardiac death due to ventricular tachyarrhythmias.
The FDA has classified this recall as Class II. Patients with these devices should contact their healthcare provider for evaluation and to determine if any action is necessary.
The recalled product
- Product
- 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
- Manufacturer
- Sorin Group Italia SRL - CRF
- Affected units
- 125
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Sorin Group Italia SRL - CRF under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Sorin Group Italia SRL - CRF
See all →- HighSorin Platinium ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
- HighSorin Platinium ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
- HighSorin Platinium ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
- SevereSorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
- HighSorin Platinium CRT-D Recall for Potential Overconsumption After ESD or MRI
FDA (Devices) · 2017-10-04
Same hazard · electrostatic discharge
See all →- HighMINC+ Benchtop Incubator Recalled for Temperature Control Loss Risk
FDA (Devices) · 2024-01-24
- SeverePolaris Sportsman and Scrambler 1000 S ATVs recalled for fire hazard
CPSC · 2023-01-05
- SeverePolaris Snowmobiles Recalled Due to Fire Hazard from Fuel Tank
CPSC · 2022-11-17
- ModerateAbbott Afinion 2 Power Supply Recall for Electrostatic Discharge Risk
FDA (Devices) · 2020-06-10
- HighSiemens Medical Solutions Recalls Artis zee and Artis zeego Foot Switches
FDA (Devices) · 2018-03-07