Events

Recall of Device Recall Affinity Pediatric Arterial Filter

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
    65732
  • Event Risk Class
    Class 2
  • Event Number
    Z-1966-2013
  • Event Initiated Date
    2013-06-14
  • Event Date Posted
    2013-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119981
  • 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
    Filter, blood, cardiopulmonary bypass, arterial line - Product Code DTM
  • Reason
    Medtronic is recalling 148 affinity pediatric arterial filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.
  • Action
    Customer communication was initiated verbally on June 14, 2013, to the 4 affected customers to quarantine any un-used units. An Urgent Medical Device Recall letter, dated June 26, 2013. was mailed to customers on June 28, 2013. The Urgent Medical Device letter referenced that the letter is in follow-up to the previous phone call. It identified the affected product, stated the issue with the 2 affected lot numbers and health risks, and asked that the affected devices be quarantined for return to Medtronic. If you have any questions please contact your Medtronic Sales representative or Lifeline Technical Services at 1-877-526-7890. 1-763-526-7890. Update: Customer communication to the newly identified customer was initiated verbally on August 20,2013, with the customer letter delivery beginning AUG 27, 2013. A Medtronic representative is available to facilitate the return of affected product.

Device

Device Recall Affinity Pediatric Arterial Filter
  • Model / Serial
    Lot Numbers: 12635577 and 12637041 Updated infrormation on 9/6/13 to include Lot # 12645672
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore.
  • Product Description
    Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. || Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. || The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface.
  • 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