Events

Recall of OVATIO

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group Italia SRL - CRF.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77139
  • Event Risk Class
    Class 2
  • Event Number
    Z-2112-2017
  • Event Initiated Date
    2017-04-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155018
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Defibrillator, implantable, dual-chamber - Product Code MRM
  • Reason
    Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.
  • 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.

Device

OVATIO
  • Model / Serial
    Product Code: OH61U, OH60U, OH62U
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    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.
  • Manufacturer
    Sorin Group Italia SRL - CRF

Manufacturer

Sorin Group Italia SRL - CRF
  • Manufacturer Address
    Sorin Group Italia SRL - CRF, Via Crescentino, Saluggia, VC Italy
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA