Events

Recall of Device Recall Hercules 360 Universal Stabilizing Arm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

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
    76344
  • Event Risk Class
    Class 2
  • Event Number
    Z-1201-2017
  • Event Initiated Date
    2014-08-20
  • Event Date Posted
    2017-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152881
  • 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
    stabilizer,heart - Product Code MWS
  • Reason
    Terumo cardiovascular systems (terumo cvs) is recalling certain lots of hercules tm 360 universal stabilizing arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. while the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.
  • Action
    Terumo Cardiovascular Systems has contact all affected parties (user facilities and consignees) via a Customer Notification Letter that advises of the recall activity.

Device

Device Recall Hercules 360 Universal Stabilizing Arm
  • Model / Serial
    Serial Number Range 70194 through 70504
  • Product Classification
    Cardiovascular Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
  • Product Description
    Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA