Events

Recall of Device Recall INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LivaNova USA.

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
    79863
  • Event Risk Class
    Class 2
  • Event Number
    Z-1919-2018
  • Event Initiated Date
    2018-03-13
  • 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=163800
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Reason
    Some integrated sterile inspire family products contain an incorrect expiration date printed in the unique device identification (udi) bar code and readable code just beneath the barcode. specifically, the expiration date is reported as ddmmyy instead of yymmdd. the expiration date in the applicable field on the package labels are correct as printed.
  • Action
    On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.

Device

Device Recall INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy rese...
  • Model / Serial
    Lot:1709190230, UDI: (01)08033178112369(17)200917(10)1709190230, Exp: 09/17/2020; Lot: 1710260210, UDI: (01)08033178112369(17)201024(10)1710260210, Exp: 10/24/2020
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NJ, CA, MN, MO, MA
  • Product Description
    Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 || The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less.
  • Manufacturer
    LivaNova USA

Manufacturer

LivaNova USA
  • Manufacturer Address
    LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA