Devices

Device Recall ThinFlex Venous Return Cannulae

  • Model / Serial
    Lot Number 58449974
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
  • Product Description
    Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 || Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
  • Manufacturer
    Edwards Lifesciences Research Medical, Inc.
  • 1 Event

Manufacturer

Edwards Lifesciences Research Medical, Inc.
  • Manufacturer Address
    Edwards Lifesciences Research Medical, Inc., 6864 South 300 West, Midvale UT 84047
  • Manufacturer Parent Company (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall ThinFlex Venous Return Cannulae
  • Model / Serial
    Lot Number 58448226
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
  • Product Description
    Thin-Flex Venous Return Cannulae, 33/43 Fr. x 39 cm, REF TF3343OA, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
  • Manufacturer
    Edwards Lifesciences Research Medical, Inc.
Device Recall ThinFlex Venous Return Cannulae with Duraflo coating
  • Model / Serial
    Lot Number 58440709
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
  • Product Description
    Thin-Flex Venous Return Cannulae with Duraflo coating, REF DTF3343O, 33/43 Fr. x 39 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
  • Manufacturer
    Edwards Lifesciences Research Medical, Inc.