Events

Recall of Device Recall Medtronic HMS PLUS, Hemostasis Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic 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
    54251
  • Event Risk Class
    Class 2
  • Event Number
    Z-1070-2010
  • Event Initiated Date
    2009-12-14
  • Event Date Posted
    2010-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87953
  • 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
    Analyzer, heparin, automated - Product Code JOX
  • Reason
    Recently the us food and drug administration (fda) issued an alert, communicating a change in the united states pharmacopeia (usp) monograph for heparin, introducing a new usp reference standard that will in effect, change potency, and harmonize the usp unit dose with the who international standard (iu) unit dose. users of the medtronic hemostasis management system (hms plus) must be aware o.
  • Action
    Consignees were sent a Medtronic "Urgent Medical Device Notice' dated December 14, 2009. The letter was addressed to "Valued Customer". The letter described the product and the problem. Advised customers to configure the HMS Plus appropriately. The Field Notification was sent to all current HMS Plus users. The current HMS Plus users were identified by the sales of HMS Plus disposable product -Heparin Assay Cartridges from the period of August 1, 2008 to date. This time was considered appropriate, being more than twice the longest expiration date of any of the HMS disposable.

Device

Device Recall Medtronic HMS PLUS, Hemostasis Management System
  • Model / Serial
    Catalogue Number 30514
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    All states in USA (Including DC) except RI and VT.
  • Product Description
    Medtronic HMS PLUS, Hemostasis Management System, Model 30514. || It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. || It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Manufacturer Address
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • 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