FDA Device recall Z-0555-2024
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal…
- FDA Device
- Class II
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class II recall of CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal… by Maquet Medical Systems Usa, citing certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble senso….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0555-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-06 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | US |
Product
CARDIOHELP-i Heart Lung Support System- A 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 Part Number: 701072780, (CARDIOHELP-I US); 701048012 (CARDIOHELP-I NON US)
Reason
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp
Identifiers
| code_info | UDI Code: 04058863074863 (CARDIOHELP-I US); 04037691658384 (CARDIOHELP-I NONUS). All serial numbers up to and including 90415177. |
|---|
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-0555-2024%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.