Events

Recall of Pioneer Plus Catheter PPlus 120

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic CardioVascular.

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
    55541
  • Event Risk Class
    Class 2
  • Event Number
    Z-0864-2011
  • Event Initiated Date
    2010-04-30
  • Event Date Posted
    2011-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91085
  • 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, percutaneous - Product Code DQY
  • Reason
    Needles may fail to retract and thus cause injury.
  • Action
    Medtronic sent an Urgent Medical Device Safety Information letter to all affected customers. The letter identified the product, the problem,and the action to be taken by the customer. Sales Representatives were to contact each account and complete an acknowledgement form indicating the Physicians had been notified. For questions regarding this recall customers were to contact their local representative.

Device

Pioneer Plus Catheter PPlus 120
  • Model / Serial
    All Lots, no serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Germany, Netherlands, Slovakia, and Spain
  • Product Description
    Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculature over a standard length, commercially available 0.014" (0.36 mm) Rapid Exchange (RX) tracking guide wire. It utilizes an extendable, hollow Nitinol guide tip (needle) to facilitate the redirection and placement of a 0.014 (0.36 mm) Over the Wire (OTW) guide wire into peripheral vessels. Specification Developer: Medtronic, Minneapolis, MN. Manufactured by: Accellent, Laconia NH || The Pioneer Plus Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Pioneer Plus Catheter also provides an intra-luminal cross-sectional ultrasound image of the area of interest to facilitate placement of guide wires beyond stenotic lesions (e.g., sub-total, total or chronic total occlusions) prior to additional intervention (i.e. PTCA, stent, etc.). The Pioneer Plus Catheter is not indicated for use in the coronary or cerebral vasculature.
  • Manufacturer
    Medtronic CardioVascular

Manufacturer

Medtronic CardioVascular
  • Manufacturer Address
    Medtronic CardioVascular, 3576 Unocal Pl, Santa Rosa CA 95403
  • 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