Events

Recall of Device Recall Transfer Spike (Blood processing accessory)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Cardiovascular Revascularization & Surgical Therap.

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
    51952
  • Event Risk Class
    Class 2
  • Event Number
    Z-1424-2009
  • Event Initiated Date
    2009-02-25
  • Event Date Posted
    2009-06-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81730
  • 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
    Blood processing accessory - Product Code DWE
  • Reason
    Sterility may be compromised. non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent ethylene oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death.
  • Action
    Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" letter dated March 5, 2009. The letter was addressed to Risk Manager. The letter described the product and problem and requested the consignee to complete, sign and return the certificate acknowledgement.

Device

Device Recall Transfer Spike (Blood processing accessory)

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • Manufacturer Address
    Medtronic Cardiovascular Revascularization & Surgical Therap, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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