CareFusion AVEA ventilator — Class I medical device recall Z-1609-2015
Terminated recall by Carefusion 211 Inc dba Carefusion, reported 2015-06-03, distributed nationwide. A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm.
| Recall number | Z-1609-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 211 Inc dba Carefusion, Yorba Linda, CA, United States |
| Recall initiated | 2015-04-03 |
| Classified | 2015-05-26 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2018-07-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BO, BR, BS, BZ, CA, CL, CN, CO, CR, CY, CZ, DE, DO, EC, EE, EG, ES, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LT, LV, MA, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SG, SI, SK, TH, TN, TR, TW, UY, VE, VN, ZA |
| Reason classes | device malfunction |
| Serial numbers | 3558, ACV01718, ADV01025, ADV01031, ADV01052, ADV01067, ADV01501, ADV01518, ADV01522, ADV01531, ADV01535, ADV01538, ADV01553, ADV01559, ADV01570, ADV01575, ADV01585, ADV01587, ADV01592, ADV01637, ADV01638, ADV01645, ADV01689, ADV01692, ADV01696 and 475 more |
Product
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Reason for recall
A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
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-1609-2015. 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.