Medtronic Inc. Cardiac Rhythm Disease Management: Medical Device Recall in 2013 - (Recall #: Z-1966-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 14, 2013

Date Posted: August 21, 2013

Recall Number: Z-1966-2013

Event ID: 65732

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.

Status: Terminated

Product Quantity: 153 devices.

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated