Events

Recall of ENDOPATH XCEL BLUNT TIP TROCAR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    72235
  • Event Risk Class
    II
  • Event Initiated Date
    2010-10-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This recall has been initiated because ethicon endo-surgery is aware of an increase in reports of leaking in the endopath xcel with optiview technology trocars which can potentially lead to loss of pneumoperitoneum during a surgical procedure. pneumoperitoneum loss can have a range of potential consequences from customer annoyance to conversion from laparoscopic to open surgery.

Device

ENDOPATH XCEL BLUNT TIP TROCAR
  • Model / Serial
    Model Catalog: H12LP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D12LT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D12XT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D11LT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B11LPH (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: B12LP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: B11LP (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: B12LPH (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: K12LT (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: K11LT (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CB12LT (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: CB11LT (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: B12XT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B12SRT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B11LT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B12LT (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: B11LTH (Lot serial: >100 NUMBERS CON
  • Product Description
    ENDOPATH XCEL BLUNT TIP TROCAR
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.