Events

Recall of Device Recall Pressure Monitoring Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edward 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
    71971
  • Event Risk Class
    Class 2
  • Event Number
    Z-2776-2015
  • Event Initiated Date
    2015-07-31
  • Event Date Posted
    2015-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139472
  • 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
    Transducer, pressure, catheter tip - Product Code DXO
  • Reason
    Flow restriction issues in a trifurcated iv set included in the pressure transducer kits. a restriction of the flow of iv fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.
  • Action
    Edwards sent an Urgent Product Recall Letter on August 10, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm's letter requests that customers return any of the units that they currently have in inventory. The letter requests that customers verify the inventory that has been pre-populated on the acknowledgment form, and complete the remainder of the form. The firm states to fax back the acknowledgment form within three days of receipt of notification to Edwards Customer Service at 1-800-422-9329. The firm requests to call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the implicated lots as well as to obtain information about product replacment. The notification states to call for an RGA prior to returning any unused product and return unused product to the firm at Edwards Lifesciences Return Goods. Any questions the firm states to contact Edwards Customer Service at 1-800-424-3278.

Device

Device Recall Pressure Monitoring Kit
  • Model / Serial
    Model # Lot # Expiration Date PX2X3 59987950 3/12/2017 PX2X3 60008882 3/24/2017 PX2X3 60043561 5/1/2017 PX3X3272 59994227 3/8/2017 PX3X3272 60025936 4/15/2017 PX3X3AN 60030889 4/17/2017 PX3X3AN 60008883 3/26/2017 PXAK2066 60025499 2/27/2017 PXAVMP3 60036757 4/27/2017 PXMK1970 60001398 4/16/2017 PXMK2043 59994210 3/9/2017 PXMK2043 60001412 3/17/2017 PXMK2043 60020166 4/5/2017 PXMK2043 60030868 4/26/2017 PXMK2144 60019038 4/17/2017 PXMK2217 59994267 3/12/2017 PXMK2217 60030969 4/20/2017 PXMK2217 60020235 4/15/2017 PXVK0458 59983333 4/6/2017 PXVK1079 59994195 3/11/2017 PXVK1079 60020153 3/31/2017 PXVMP2X31 59998630 3/12/2017 PXVMP2X31 59999004 3/13/2017 PXVMP2X31 59999006 3/13/2017 PXVMP3X31 59994223 3/13/2017 PXVMP3X31 60049581 4/23/2017 PXVMP3X32 60025874 3/31/2017 T001746A 60036771 4/30/2017 T001759A 59976102 3/10/2017 T001759A 60014134 3/31/2017 T001759A 60020177 4/13/2017 T001759A 60049570 5/4/2017 T330V11A 60014160 3/29/2017 T333F00A 59987991 3/9/2017 T333F00A 60001468 3/16/2017 T333F00A 60022033 3/13/2017 T334041A 60008925 3/25/2017 T334041A 60049612 5/5/2017 T336547B 60008919 3/27/2017 T337305B 59987992 3/11/2017 T337305B 60001473 3/17/2017 T391314A 60020222 3/29/2017 T391T01A 60014163 3/30/2017 T395606B 60022034 3/13/2017 T395606B 60025971 4/14/2017 T430140A 60014177 3/31/2017 T430609A 60001486 3/16/2017 T430609A 60043616 4/27/2017 T431305A 60008942 3/25/2017 T431305A 60059909 5/8/2017 T440B20B 59994257 3/13/2017 T440B20B 60030953 4/17/2017 T440B21A 60025987 4/15/2017 T440B21A 59976182 3/11/2017 T440B26B 60030938 4/17/2017 T440B26B 60049616 5/4/2017 T443422A 60036750 4/29/2017 T443422A 60020223 4/15/2017 T449103B 60008929 3/24/2017 T449103B 60043599 4/28/2017 T450544A 60030944 4/20/2017 T494C00B 60020168 3/19/2017 T494C00B 60001415 3/25/2017 T494C00B 60043543 4/21/2017 T530116B 60022035 3/13/2017 T530116B 60008937 3/24/2017
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia.
  • Product Description
    Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
  • Manufacturer
    Edward Lifesciences, Llc

Manufacturer

Edward Lifesciences, Llc