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

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

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