Events

Recall of NC Sprinter; Rapid Exchange Balloon Dilatation Catheter

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

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
    66334
  • Event Risk Class
    Class 2
  • Event Number
    Z-2302-2013
  • Event Initiated Date
    2013-09-16
  • Event Date Posted
    2013-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122073
  • 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
    Catheters, transluminal coronary angioplasty - Product Code LOX
  • Reason
    Compliance chart included in lot 207002011 of the nc sprinter rx 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter beginning September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that your facility has received affected NC Sprinter RX Balloon Dilatation Catheters as noted in the attached customer notification detail report. Consequently, Medtronic is asking you to take the following actions: 1. Remove and quarantine all affected catheters that remain in your inventory. 2. Return the affected catheters to Medtronic. A Medtronic representative can assist in facilitating the return and replacement of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Medtronic has taken the necessary steps to prevent any future shipment of mislabeled product. Regulatory agencies will be notified about this recall as applicable. Please share this notification with others in your organization as appropriate. If any NC Sprinter RX Balloon Dilatation Catheters within the scope of this recall have been forwarded to another facility, please notify that facility accordingly and facilitate the retrieval of the affected product. We appreciate your cooperation and apologize for the inconvenience that this issue may cause. Should you have any questions, please contact your local Medtronic representative.

Device

NC Sprinter; Rapid Exchange Balloon Dilatation Catheter
  • Model / Serial
    Lot number 207002011; Exp 5-13-2015.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.
  • Product Description
    NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; || Sterile; 2.25 mm; Model NCSP22512X. || Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 || The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaque balloon marker(s) enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
  • Manufacturer
    Medtronic Vascular, Inc.

Manufacturer

Medtronic Vascular, Inc.
  • Manufacturer Address
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • 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