Recall Z-0555-2024 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
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)
| Date | Dec 14, 2023 (initiated Nov 6, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Labeling design |
| Action | Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device- Correction Customer Letter to US consignees issued on 11/6/23 via express mail. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any affected CARDIOHELP-i in your inventory. " Please review, download, and print the updated IFU for these products at: https://us.getinge.com/l/950532/2023-10-13/ppb1d2 " Please remove and destroy any previous versions of the IFU at your facility. " As noted in the Key User Functions section of the IFU: " Befo |
| Quantity | 1595 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, G |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |