Events

Recall of Device Recall Mullins Transseptal Catheter Introducer Sheath

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

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
    65757
  • Event Risk Class
    Class 2
  • Event Number
    Z-1876-2013
  • Event Initiated Date
    2013-07-08
  • Event Date Posted
    2013-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120059
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Medtronic identified a specific labeling issue for specific lots of mullins transseptal catheter introducer sheath, model 008551, in which packages labeled as mullins 7f (french) may actually contain an 8f(french) dilator. medtronic is requesting the return of potentially mis-labeled mullins transseptal catheter introducer 7 french sheaths. due to the differences in size, an 8f dilator will not.
  • Action
    Consignees were sent on 7/8/2013 a Medtronic, Inc " Urgent Medical Device Recall" letter dated 8 July 2013. The letter was addressed to Healthcare Professionals. The letter identified the problem and the product involved in the recall. Advised consignees to remove and quarantine the product from their inventory and return the product. Requested consignees to complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. If the product has been further distributed advised consignees to please notify them of the recall.

Device

Device Recall Mullins Transseptal Catheter Introducer Sheath
  • Model / Serial
    Lot Numbers: 50672012, 50676944, 50683123, 50693426, 50710622.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE.
  • Product Description
    Medtronic Mullins Transseptal Adult 7F, REF 008551. || Intended for the introduction of cardiovascular catheters into the left side of the heart.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • 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