Events

Recall of Device Recall Stealth 360degree Obital Atherectomy Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiovascular Systems, 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
    62406
  • Event Risk Class
    Class 2
  • Event Number
    Z-1959-2012
  • Event Initiated Date
    2012-06-18
  • Event Date Posted
    2012-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110453
  • 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
    Catheter, peripheral, atherectomy - Product Code MCW
  • Reason
    Csi has initiated a recall on specific lot numbers of stealth 360-degree orbital atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
  • Action
    Phone calls to affected sites began June 15, 2012 to quarantine the product. These same sites were also notified with an Urgent Medical Device Recall letter, dated June 18, 2012, via FedEx and e-mail (where available) on June 18, 2012. The letter notified each customer to remove from use and return the recalled product. The customer was instructed to complete a Customer Acknowledgement Form and return it with the device(s) being returned in the Returned Goods Authorization kit provided. Customers with questions can contact customer service at 1-877-274-0901. For any questions regarding this recall call 651-259-2805.

Device

Device Recall Stealth 360degree Obital Atherectomy Device
  • Model / Serial
    Lot s: 59887, 59888, 61516, and 61517.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
  • Product Description
    CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. || The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
  • Manufacturer
    Cardiovascular Systems, Inc.

Manufacturer

Cardiovascular Systems, Inc.
  • Manufacturer Address
    Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • Manufacturer Parent Company (2017)
    Cardiovascular Systems, Inc.
  • Source
    USFDA