Events

Recall of Vapotherm

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

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
    69116
  • Event Risk Class
    Class 2
  • Event Number
    Z-2704-2014
  • Event Initiated Date
    2014-08-13
  • Event Date Posted
    2014-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129676
  • 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
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • Reason
    Disposable patient circuit that allows water to leak into the center gas lumen.
  • Action
    Vapotherm issued an Initial Notification on August 13, 2014. The letter was updated on August 20, 2014 to include two additional lots. The recall letter notified users that this defect is easily detectable during normal use and the probability of serious injury or death is remote. The letter was sent to raise awareness of the recent increase in incidence rate of this issue and reminded users of the requirement in the operating manual that requires that the cannula be connected to the patient only after the set temperature is reached. The letter also advised patient care personnel not to use, or to discontinue use of any Disposable Patient Circuit if water is observed leaking into the center lumen or from the cannula. They were instructed to replace the device and report the defect to Vapotherm immediately for further investigation. Should you have any questions please contact our technical support team at Email: ts@vtherm.com (US) 855.557.8276 (INTL) 1-603.658.5121

Device

Vapotherm
  • Model / Serial
    Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwait, and Italy.
  • Product Description
    Vapotherm Precision Flow,Disposable Patient Circuit || PF-NODPC-Low. || For use with the Precision Flow system and Ikaria INOmax DSIR || ¿ System. || This DPC allows clinicians to administer nitric oxide non-invasively via high || flow nasal cannula. In the Precision Flow High Flow Therapy application, a || special disposable patient circuit re-routes the gas to the INOmax injector || module then back into the Precision Flow system
  • Manufacturer
    Vapotherm, Inc.

Manufacturer

Vapotherm, Inc.
  • Manufacturer Address
    Vapotherm, Inc., 22 Industrial Dr Ste 1, Exeter NH 03833-4557
  • Manufacturer Parent Company (2017)
    Vapotherm Inc.
  • Source
    USFDA