Agency classClass IIOur severity:High FDA (Devices)·Z-3233-2017·Announced 2017-10-04

Sorin Platinium CRT-D Recall for Potential Overconsumption After ESD or MRI

Sorin Group is recalling 68 Platinium CRT-D devices due to a possibility of overconsumption of the device following electrostatic discharge or an MRI scan.

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/CRT-D) where a functional failure (overconsumption) could lead to serious harm, but the source text explicitly states no illnesses or injuries have been reported, capping the score at 3 per the rubric.

Plain-English summary

Sorin Group Italia SRL is recalling 68 units of the Platinium CRT-D 1741 (Model Number TDF037U) implantable cardioverter defibrillators. The recall covers devices with all serial numbers that were distributed nationwide in the United States.

The recall is being 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 device is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias, such as those who have survived a cardiac arrest or have recurrent sustained ventricular tachycardia.

The source text does not specify specific actions for consumers or patients to take, nor does it report any illnesses or injuries associated with this recall.

The recalled product

Product: 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…
Manufacturer: Sorin Group Italia SRL - CRF
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: device-malfunction
electrostatic-discharge
Affected units: 68

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 →

Same manufacturer · Sorin Group Italia SRL - CRF

See all →

Severe
Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
High
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
High
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
High
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04
Severe
Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk
FDA (Devices) · 2017-10-04

Same hazard · device malfunction