HLS/HIT Set Advanced with Bioline and/or Softline Coating Console… — Class II medical device recall Z-1690-2015
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-1690-2015 |
|---|---|
| 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 |
| Reason classes | packaging |
| Model numbers | 2797, 5050, 70105, 70105.2786, 70105.2794, 7050 |
Product
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.
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-1690-2015. 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.