Medtronic Affinity Pediatric Arterial Filter — Class II medical device recall Z-1966-2013
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2013-08-21, distributed in IL, MS. Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited qua
| Recall number | Z-1966-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2013-06-14 |
| Classified | 2013-08-14 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2014-03-07 |
| Distributed | IL, MS |
| Countries outside the US | AR, SG, ZA |
| Quantity | 153 devices |
| Reason classes | specification failure |
| Lot numbers | 12635577, 12637041, 12645672 |
| Model numbers | M272403C, S4014 |
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.
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.