Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling 72 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are classified as Severe (4).
Plain-English summary
Sorin Group Italia SRL is recalling 72 units of the Platinium VR DF4 1240 implantable cardioverter defibrillator (ICD), Model Number TDF035U. The recall covers all serial numbers and involves devices distributed nationwide in the United States.
The recall is issued because there is a possibility of overconsumption of the device 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.
Patients with these specific devices should contact their healthcare provider to discuss the recall and determine if any action is necessary.
The recalled product
- Product
- 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…
- Manufacturer
- Sorin Group Italia SRL - CRF
- Affected units
- 72
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 →- SevereSorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
- HighSorin Platinium ICDs Recalled for Potential Overconsumption Risk
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- HighSorin Platinium ICDs Recalled for Potential Overconsumption Risk
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