QUADROX-i Neonatal without integrated arterial filter and VHK 11000 — Class I medical device recall Z-0436-2019
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2018-12-05, distributed nationwide. There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4
| Recall number | Z-0436-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2018-10-25 |
| Classified | 2018-11-28 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2020-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BE, BR, CA, CH, CL, CN, CO, DE, EG, ES, FR, GB, IE, IN, IT, JP, KR, LB, MX, MY, NL, PK, PL, PT, RS, RU, SA, SE, TH, TR, TW, UA, UY, ZA |
| Quantity | 490 in |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04037691780139 |
| Lot numbers | 92212343, 92214685, 92225187 |
| Model numbers | 701055120 |
Product
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Reason for recall
There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
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-0436-2019. 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.