Events

Recall of Device Recall ProventSR or Provent50

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ventus Medical, 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
    61129
  • Event Risk Class
    Class 3
  • Event Number
    Z-1033-2012
  • Event Initiated Date
    2012-02-03
  • Event Date Posted
    2012-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107359
  • 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
    Expiratory resistance valve, intranasal, for obstructive sleep apnea - Product Code OHP
  • Reason
    A discrepancy was found during inspection of a returned unit that the lot number and sku on cartoon did not match.
  • Action
    Ventus Medical sent a Urgent Medical Device Correction Letter dated February 3, 2012, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. There is no health hazard associated with the affected devices or with the continued use of the affected devices. Ventus Medical wanted Customers to be aware of the problem so they can respond to patients if inquiries are received. A sample letter to patients was also provided, should physicians choose to provide it to patients. Questions may be directed to Ventus Medical Territory Business Manager at 650-632-4199.

Device

Device Recall ProventSR or Provent50
  • Model / Serial
    Catalog number MRS0227; Lot number: 14261182.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of OH, TX, IL, OR, CA, FL and NY.
  • Product Description
    Provent -SR - Sleep Apnea Therapy-SR (standard resistance). || Prescription only, Single Use; || Packed 30 units per box || Manufactured in the USA by Ventus Medical Inc. || 1301 Shoreway Road, Suite 425; || Belmont, CA 94002 || Used in the treatment of obstructive sleep apnea.
  • Manufacturer
    Ventus Medical, Inc.

Manufacturer

Ventus Medical, Inc.
  • Manufacturer Address
    Ventus Medical, Inc., 1301 Shoreway Rd Ste 425, Belmont CA 94002-4154
  • Manufacturer Parent Company (2017)
    Ventus Medical Inc.
  • Source
    USFDA