Recall Z-0595-2024 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
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
| Date | Sep 30, 2024 (initiated Nov 14, 2023) |
| Status | Open, Classified |
| Reason | CARDIOHELP-i System was not properly tested to measure leakage current |
| Root cause | Process design |
| Action | Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device Correction Letter to U.S, consignees November 14, 2023 via FedEx. 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. " Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned |
| Quantity | 1594 units |
| Distribution | Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |