FDA Device recall Z-0605-2024
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
- FDA Device
- Class II
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class II recall of Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802 by Maquet Medical Systems Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0605-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-13 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | US |
Product
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Reason
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.
Identifiers
| code_info | UDI-DI 04058863074863 and 04037691658384 All serial numbers up to and including 90413927 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Maquet Medical Systems Usa
- CARDIOHELP-i System
FDA Device · Class II · 2024-05-22 · Maquet Medical Systems Usa - Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077
FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa - BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078
FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa - Bubble Sensor (REF: 70105.5720)
FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa - BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553
FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
All Maquet Medical Systems Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0605-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.