Agency classClass IIOur severity:High FDA (Devices)·Z-3232-2017·Announced 2017-10-04

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) where a functional failure (overconsumption) could lead to serious harm, but the source text describes a 'possibility' of the issue without reporting specific injuries or deaths, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Sorin Group Italia SRL is recalling 86 units of Platinium DR DF4 1540 Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). The recall covers Model Number TDF036U with UDI/GTIN 08031527015477. These devices are indicated for patients at high risk of sudden cardiac death due to ventricular tachyarrhythmias.

The recall is issued because there is a possibility of overconsumption of the device's energy following an ElectroStatic Discharge (ESD) during implant surgery or a Magnetic Resonance Imaging (MRI) scan. This potential malfunction could affect the device's ability to deliver appropriate therapy.

The affected units were distributed nationwide in the United States. The recall includes all serial numbers for the specific model. Patients with these implanted devices should contact their healthcare provider to discuss the recall and determine if any action is necessary.

The recalled product

Product: Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, 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
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: device-malfunction
electrostatic-discharge
mri-interference
Affected units: 86

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 CRT-D Recall for Potential Overconsumption After ESD or MRI
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