Device product
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.
Z-1966-2013
Product summary
- Event
- Event 65732
- Status
- Terminated
- Classification
- Class II
- Quantity
- 153 devices.
- Official record key
device-enforcement:Z-1966-2013
Official wording
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.
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.
Derived failure modes
-
Foreign material or chemical contamination
particulate