Events

Recall of Medtronic (Covidien)Palindrome Precision Chronic Catheter Kit

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
    72416
  • Event Risk Class
    Class 2
  • Event Number
    Z-0329-2016
  • Event Initiated Date
    2015-10-14
  • Event Date Posted
    2015-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140974
  • 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
    Catheter, hemodialysis, implanted, coated - Product Code NYU
  • Reason
    Incorrectly packaged with a 90 degree bend at the distal tip.
  • Action
    The firm, Medtronic (Covidien), sent an "URGENT MEDICAL DEVICE RECALL" letter dated 10/16/2015 to their customers. The letter described the product, problem, and actions to be taken. Customers were instructed to quarantine and discontinue use of the product, return affected product and complete and return the RECALLED PRODUCT RETURN FORM via Fax to Medtronic to (800)-895-6140 or email to: feedback.customerservice@Covidien.com/Distributor to (203) 492-7719 or email to: PalCathFCA@Covidien.com. Questions or concerns contact your Medtronic representative or Customer Service at (800) 882-5878.

Device

Medtronic (Covidien)Palindrome Precision Chronic Catheter Kit
  • Model / Serial
    Lot Numbers: 1503500094, 1431900098, 1435800009
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Canada, Belgium, Chile, Panama, Denmark, France, Germany , Netherlands,Spain, Switzerland, and United Kingdom.
  • Product Description
    Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm || Item Number: 8888145042 || The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant length are indicated for femoral insertion.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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