Recall of Device Recall Dolphin Inflation Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DeRoyal Industries 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Syringe, balloon inflation - Product Code MAV
  • Reason
    Lack of sterility assurance. there is a defect in the primary packaging of the device, which may compromise the device sterility.
  • Action
    DeRoyal issued an Urgent Recall Notice dated June 7, 2017, to all affected customers. The customers were asked to identify the affected products and return the provided notice of return form back to DeRoyal indicating if replacement or credit is requested. Customers with questions were instructed to call 888-938-7828 or email For questions regarding this recall call 865-938-7828.


  • Model / Serial
    Lot Number 15125173
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution to MD, NY, and IL
  • Product Description
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, || Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
  • Manufacturer


  • Manufacturer Address
    DeRoyal Industries Inc, 200 Debusk Ln, Powell TN 37849-4703
  • Manufacturer Parent Company (2017)
  • Source