Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling Platinium ICDs and CRT-Ds 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device (ICD) with a theoretical risk of harm (overconsumption) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Sorin Group Italia SRL is recalling 154 units of Platinium CRT DF1 1711 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). 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 affected devices are distributed nationwide in the United States. The recall covers all serial numbers for the specific model TDF033U. The product is indicated for use in patients at high risk of sudden cardiac death due to ventricular tachyarrhythmias.
Consumers and healthcare providers should contact the recalling firm for further instructions on how to proceed with the recall and any necessary device management.
The recalled product
- Product
- 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…
- Manufacturer
- Sorin Group Italia SRL - CRF
- Affected units
- 154
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
FDA (Devices) · 2017-10-04
- HighSorin Platinium CRT-D Recall for Potential Overconsumption After ESD or MRI
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
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