Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The… — Class II medical device recall Z-1689-2015
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2015-06-03, distributed nationwide. A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quad
| Recall number | Z-1689-2015 |
|---|---|
| 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 | 2015-03-05 |
| Classified | 2015-05-28 |
| Reported by FDA | 2015-06-03 |
| Terminated | 2019-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CH, CN, CO, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IS, IT, JP, KR, LT, LU, LV, MT, MX, NL, NO, PL, PT, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UY |
| Quantity | 10,199 units |
| Reason classes | packaging |
| Model numbers | 3824, 70000, 70105, 70105.3815 |
Product
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Reason for recall
A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
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-1689-2015. 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.