Events

Recall of Device Recall InSync III

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
    72618
  • Event Risk Class
    Class 2
  • Event Number
    Z-0342-2016
  • Event Initiated Date
    2015-11-09
  • Event Date Posted
    2015-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141673
  • 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
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
  • Reason
    Medtronic has confirmed an issue with insync iii crt-pacemaker devices related to long-term battery performance. the root cause is unexpected high battery impedance.
  • Action
    Medtronic sent an Urgent Medical Device Correction letter dated November 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Medtronic records indicate you are following one or more patients with this device. Please see the enclosed Physician/Patient Detail Report. We regret any difficulties this may cause you and your patients. We will continue to monitor device performance and provide regular updates in our product performance report available at wwwp.medtronic.com/productperformance/. Medtronic Patient Services is available to assist patients at 800-551-5544. Medtronic will offer a supplemental device warranty. Contact your sales representative for terms and conditions. If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

Device

Device Recall InSync III
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary , India, Indonesia, Iran, Ireland, Israel, Italy, Japan Jordan, Kazakhstan, Kenya, Kuwait, Korea, Latvia, Luxembourg, Lebanon, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius , Mexico, Morocco, Netherlands, New Zealand, Norway,Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad, Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Vietnam.
  • Product Description
    Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Manufacturer Address
    Medtronic Inc., 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