Events

Recall of Device Recall Cytosponge Cell Collection Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien, 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
    74300
  • Event Risk Class
    Class 2
  • Event Number
    Z-2123-2016
  • Event Initiated Date
    2016-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147105
  • 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
    Esophagoscope (flexible or rigid) - Product Code EOX
  • Reason
    Medtronic is recalling all lots of the covidien cytosponge cell collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.
  • Action
    The firm, Medtronic, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 6, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and discontinue use; return affected product to Medtronic/Covidien, Quality Department, 540 Oakmead Parkway, Sunnyvale CA 94085; complete and return the RECALLED PRODUCT RETURN FORM by email to Customer Service feedback.customerservice@Covidien or fax to (800)-895-6140 if product purchased directly from Medtronic; or by email to Quality Compliance MITGFCA@Covidien.com or fax to (203) 492-7719 if Product purchased through distributor or you have "no inventory"; and to promptly alert any other person or facilities if they have further distributed the product. All affected lots must be returned. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.

Device

Device Recall Cytosponge Cell Collection Device
  • Model / Serial
    Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
  • Product Description
    Covidien Cytosponge Cell Collection Device. || Item code CYTO-101-01. || Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.
  • Manufacturer
    Covidien, LLC

Manufacturer

Covidien, LLC
  • Manufacturer Address
    Covidien, LLC, 540 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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