Manufacturer

Sorin Group Italia SRL - CRF

9 recalls in our database name Sorin Group Italia SRL - CRF as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 5
Most recent: 2017-10-04

Of the 9 recalls from Sorin Group Italia SRL - CRF we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (56%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

SevereFDA (Devices)·Z-3228-2017·2017-10-04
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.
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 are
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3231-2017·2017-10-04
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.
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 who
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3233-2017·2017-10-04
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.
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3232-2017·2017-10-04
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.
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 who
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3230-2017·2017-10-04
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.
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 wh
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3229-2017·2017-10-04
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group Italia SRL is recalling Platinium DR 1510 ICDs due to a possibility of overconsumption following ElectroStatic Discharge (ESD) during implant surgery or MRI scans.
Product
Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, 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 are
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2114-2017·2017-05-24
Sorin Defibrillators Recalled for Undetectable Battery Depletion
Sorin Group is recalling 37 implanted defibrillators because battery depletion may be undetectable. Physicians are being notified to monitor affected patients.
Product
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac de
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2112-2017·2017-05-24
Sorin Defibrillators Recalled for Undetectable Battery Depletion
Sorin is recalling specific defibrillator models because battery depletion may be undetectable. Physicians are being notified to check affected devices.
Product
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indicated for use in patients who are at high risk of sudden cardiac d
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2113-2017·2017-05-24
Sorin Defibrillators Recalled for Undetectable Battery Depletion
Sorin Group is recalling specific implantable defibrillators because battery depletion may be undetectable, posing a risk to patients.
Product
PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF SonR 9770 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARADYM VR 8250, PARADYM DR 8550, PARADYM RF VR 9250, PARADYM RF DR 9550, INTENSIA VR 124 and INTENSIA DR 154 are indic
Category
Medical Device
Distribution
Distributed nationwide