Events

Recall of Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orbus Medical Technologies 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
    29074
  • Event Risk Class
    Class 2
  • Event Number
    Z-1075-04
  • Event Initiated Date
    2004-03-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33100
  • 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
    unknown device name - Product Code MEW
  • Reason
    Balloons have longer than expected deflation times.
  • Action
    Orbus, the recalling firm issued a recall letter on March,19 2004 to their own label distributer, Edwards Lifesciences, requesting the return of unused product. Also Orbus provided the own label distributer with a sample sub-recall letter for them to send to users/hospital accounts. Sub-accounts were asked to return product to Edwards Lifesciences.

Device

Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis
  • Model / Serial
    Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026
  • Distribution
    Product was shipped to one own label distributer in California.
  • Product Description
    The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. || The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. || Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. || Ref. Baloon-Expandable Stent and delivery System. || Catalog Numbers || SD186U14D || SD186U24D || SD366U14D || SD366U24D
  • Manufacturer
    Orbus Medical Technologies Inc

Manufacturer

Orbus Medical Technologies Inc
  • Manufacturer Address
    Orbus Medical Technologies Inc, 5363 NW 35th Ave, Fort Lauderdale FL 33309-6315
  • Source
    USFDA