Venous probe connection cable — Class II medical device recall Z-0605-2024
Ongoing recall by Maquet Medical Systems USA, reported 2023-12-27, distributed nationwide. Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable
| Recall number | Z-0605-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Medical Systems USA, Wayne, NJ, United States |
| Recall initiated | 2023-11-13 |
| Classified | 2023-12-21 |
| Reported by FDA | 2023-12-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, CA, CH, CN, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JP, KR, KW, KY, LB, LU, LV, MX, MY, NL, NO, NZ, OM, PH, PK, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TW, UA, VN, ZA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04037691658384, 04058863074863 |
| Model numbers | 701041802, 701048804, 701069333, 701072780 |
Product
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Reason for recall
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.
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-0605-2024. 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.