Sorin Group Italia SRL - CRF: 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 indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.

Recall number

Z-2113-2017

Recalling firm

Sorin Group Italia SRL - CRF

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 indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT). OVATIO CRT 6750, PARADYM CRT-D 8750, PARADYM SonR 8770, PARADYM RF CRT-D 9750, PARADYM RF SonR 9770 and INTENSIA CRT-D 174 are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The devices are also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.

Status

Terminated

Initiated

2017-04-11

Posted

not on file

Terminated

2020-05-22

Reason

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

Root cause

Software design

Action

Consignees were notified on 4/11/17 via certified letter to make users aware of the issue and what actions to take to mitigate the potential risk of re-intervention associated with undetected battery depletion. Following and implanting physicians are being instructed to do one of two things: 1. Prior to lead revision: Deactivate the shock therapies to avoid further charging1, Wait 24 hours1, and Re-interrogate the ICD or CRT-D to check the updated battery status. If RRT is reached, initiate a device replacement. Or 2. If it is not possible to wait 24 hours prior to replacing the lead, the lead revision may be performed as scheduled and the device may be replaced prophylactically during the same procedure since the battery status is unknown. For questions contact your local LivaNova representave or call LivaNova Technical Services at 877-663-7674.

Quantity

4700

Distribution

US Nationwide Distribution

Lot, serial or model codes

Product Code: ICV1199, ICV1200, ICV1179, TDF011U, TDF010U, TDF012U

510(k) numbers

not on file

PMA numbers

["P980049S050"]

Product code

MRM

Firm FEI

1000165971

Firm city

Saluggia VC

Firm state

not on file

Firm country

Italy

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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