Events

Recall of Device Recall Edwards' MHANM8 Pressure Slave Cable

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

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
    56148
  • Event Risk Class
    Class 2
  • Event Number
    Z-0160-2011
  • Event Initiated Date
    2010-06-25
  • Event Date Posted
    2010-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92746
  • 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
    Computer, diagnostic pre-programmed, single-function - Product Code DXG
  • Reason
    The recall was initiated because the edwards' mhanm8 pressure slave cable was wired incorrectly, thus will not work as stated.
  • Action
    Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number. Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned. For any questions regarding this recall call (949) 250-2007.

Device

Device Recall Edwards' MHANM8 Pressure Slave Cable
  • Model / Serial
    Lot Numbers: 58822824; 58821774
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
  • Product Description
    Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 || The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • Manufacturer Address
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA