Recall Z-1966-2013 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Medtronic Inc. Cardiac Rhythm Disease Management
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 hou
| Date | Aug 14, 2013 (initiated Jun 14, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| 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 L |
| Quantity | 153 devices. |
| Distribution | Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071253 | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 Medtronic Vascular, Jul 3, 2007 |