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U.S. Department of Health and Human Services

Class 2 Device Recall OVATIO

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  Class 2 Device Recall OVATIO see related information
Date Initiated by Firm April 11, 2017
Create Date May 18, 2017
Recall Status1 Terminated 3 on May 22, 2020
Recall Number Z-2112-2017
Recall Event ID 77139
PMA Number P980049S020 
Product Classification Defibrillator, implantable, dual-chamber - Product Code MRM
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 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.
Code Information Product Code: OH61U, OH60U, OH62U
Recalling Firm/
Manufacturer		 Sorin Group Italia SRL - CRF
Via Crescentino
Saluggia, VC Italy
Manufacturer Reason
for Recall		 Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
FDA Determined
Cause 2		 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 in Commerce 3096
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MRM and Original Applicant = MicroPort CRM USA Inc.
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