Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-1966-2013

Z-1966-2013 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

FDA device recall Z-1966-2013 was initiated by Medtronic Inc. Cardiac Rhythm Disease Management on June 14, 2013 and is designated Class II. Reason for recall: 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 parti… The recall status is terminated (terminated March 7, 2014). Affected quantity: 153 devices..

Recall Details

Product Type
Devices
Report Date
August 21, 2013
Initiation Date
June 14, 2013
Termination Date
March 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
153 devices.

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.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore.

Code Information

Lot Numbers: 12635577 and 12637041 Updated infrormation on 9/6/13 to include Lot # 12645672

Other recalls by Medtronic Inc. Cardiac Rhythm Disease Management

  • Z-0022-2016 Class II — Medtronic Medical Device Identification Card for SureScan pacemaker patients. (September 15, 2015)
  • Z-2777-2015 Class II — Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing c (September 1, 2015)
  • Z-1365-2015 Class II — Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx onl (March 23, 2015)
  • Z-1356-2015 Class II — Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Us (March 17, 2015)
  • Z-1276-2015 Class I — Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Se (February 23, 2015)
  • Z-1661-2014 Class II — Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generat (April 29, 2014)
  • Z-0998-2014 Class II — Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 ( (January 30, 2014)
  • Z-1000-2014 Class II — Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Art (January 30, 2014)
  • Z-0999-2014 Class II — Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB787 (January 30, 2014)
  • Z-0995-2014 Class II — Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (January 30, 2014)

FDA data resources