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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- 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
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