Recall Z-0420-2024 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
| Date | Dec 7, 2023 (initiated Oct 10, 2023) |
| Status | Open, Classified |
| Reason | Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia. |
| Root cause | Under Investigation by firm |
| Action | On October 10, 2023, the firm issued an Urgent Medical Device Removal letter to all affected consignees. Customers should examine their inventory to determine if they have any affected CARDIOHELP Emergency Drives in their inventory. A representative from Getinge will contact customers to ensure they have received the recall information and have taken the necessary actions. Getinge will arrange the supply of loaner replacements where needed and arrange for the return of affected devices for repair. " You may also request loaner Emergency Drive(s) from Getinge Technical Support at (888) 943-88 |
| Quantity | Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S. |
| Distribution | US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Jordan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |