Device Recall Medtronic Valley Lab

  • Model / Serial
    Affected Lot Range: 213786X through 61220121X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Cylindrical Tip Electrode 28CM || Item Code: E278628 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Affected Lot Range: 215084X through 61220127X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Straight Spatula Electrode 36C || Item Code: E277036 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Model / Serial
    Affected Lot Range: 210110X through 61250197X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Wire J-Hook Electrode 36CM || Item Code: E277236 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Model / Serial
    Affected Lot Range: 209716X through 61220115X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Curved Spatula Electrode 28CM || Item Code: E278128 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Model / Serial
    Affected Lot Range: 209358X through 60870083X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM || Item Code: E2781R28ASP || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer
  • Model / Serial
    Affected Lot Range: 209822X through 61220117X
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
  • Product Description
    Valleylab Laparoscopic Wire J-Hook Electrode 28CM || Item Code: E278228 || The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable
  • Manufacturer