Maquet ELS Cannula 15 FR — Class II medical device recall Z-0839-2013
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2013-02-27, distributed in AZ, CO, FL, TN, TX. ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
| Recall number | Z-0839-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2012-12-26 |
| Classified | 2013-02-20 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2014-05-08 |
| Distributed | AZ, CO, FL, TN, TX |
| Countries outside the US | AU, BH, CA, CH, CZ, DE, FR, GB, HK, IT, JP, KW, LB, NL, SA, SE, SG, TH, TR, ZA |
| Lot numbers | 701002797, 701005092, 701005093, 701017471, 701046644, 701050978, 92046825, 92047882, 92049129, 92049130, 92050616, 92052823, 92052913, 92053930, 92054156, 92056171, 92056804, 92056899, 92058153, 92063518, 92063587, 92065094, 92065588, 92065723, 92067382, 92068224, 92068260, 92069267, 92069286, 92069429, 92070553, 92070554, 92071806, 92071852, 92072177, 92073598, 92075413, 92076875, 92076940, 92076940OUS and 2 more |
| Model numbers | 701002797, 701005092, 701005093, 701017471, 701046644, 701050978, 92047882, 92049129, 92049130, 92050616, 92052823, 92052913, 92053930, 92054156, 92056171, 92056804, 92056899, 92058153, 92063518, 92063587, 92065094, 92065588, 92067382, 92068224, 92068260 and 14 more |
Product
Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
Reason for recall
ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0839-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.