FDA Device recall Z-0595-2024
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal b…
- FDA Device
- Class III
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class III recall of CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal b… by Maquet Medical Systems Usa, citing CARDIOHELP-i System was not properly tested to measure leakage current.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0595-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2023-11-14 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | US |
Product
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
Reason
CARDIOHELP-i System was not properly tested to measure leakage current
Identifiers
| code_info | UDI-DI: 04058863074863; 04037691658384 All serial numbers up to and including 90415172 |
|---|
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-0595-2024%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.