Events

Recall of Device Recall Medtronic Custom Perfusion System

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
    65831
  • Event Risk Class
    Class 2
  • Event Number
    Z-2104-2013
  • Event Initiated Date
    2013-07-17
  • Event Date Posted
    2013-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120350
  • 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
    Tubing, pump, cardiopulmonary bypass - Product Code DWE
  • Reason
    Medtronic was notified that edwards lifesciences has initiated a product recall for the rigid suction wand, model s099b. the wands are included within certain perfusion tubing packs that are manufactured and distributed by medtronic.
  • Action
    Metronic sent an "Urgent Field Safety Notice" letter dated July, 2013 to all affected customers. The letter described the affected product, problem and actions to be taken by User. Customerss were advised to remove and destroy all affected products. At the same time customers were informed that replacement products can be ordered by contacting their Medtronic representative. Customers were requested to complete the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. For any questions they can contact Medtronic Lifeline Technical Services at 877-526-7890 or their Medtronic representative.

Device

Device Recall Medtronic Custom Perfusion System
  • Model / Serial
    Lot: 11110924, 11178379, 11281864, 11341336, 11346822, 11357000, 11386060, 11387461, 11412023, 11448066, 11501190, 11506220, 11506223, 11528161, 11552139, 11577959, 11600953, 11623004, 11664710, 11672387, 11718344, 11719034, 11736936, 11816427, 11839402, 11843611, 11869817, 11896503, 11930457, 11995799, 11995883, 12000022, 12024743, 12024776, 12075385, 12093515, 12096289, 12166420, 12249817, 12264661, 12309956, 12374421, 12411720, 206168235, 206219230, 206325047, 206388493, 206476804, 206581948, 206597875, 206689812, 206709358, 206720707, 206851972, 206852054, 206864691, 206904419, 206991490, 207003054, 207100337, and 207121513.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide CA, IL, LA, MI and the country of CANADA
  • Product Description
    Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. || Sterilized by Ethylene Oxide, Do no Reuse. || Product Usage: || This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
  • 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