Recall Z-0897-2022 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
Cardiohelp-i Transport Guard with Transport Guard (701072525): is 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 (up to six hours). Product Code/REF Number: 701072780 (Cardiohelp-i)
| Date | Feb 18, 2022 |
| Status | Open, Classified |
| Reason | Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary. |
| Root cause | Process control |
| Action | Getinge issued Urgent Medical Device Correction Letter dated 2/18/22 via FedEx 2 day service with signature required. . Letter states reason for recall, health risk and action to take: A general decommissioning of the affected Cardiohelp-i is not required, with the consideration of the following: 1. Please examine your inventory immediately to determine if you have received any Cardiohelp-i products with one of the affected serial numbers. 2. If you have a Cardiohelp-i affected by this field correction, please examine your inventory immediately to locate all Transport Guards used with Cardiohe |
| Quantity | US: 32 units; OUS 30 units |
| Distribution | US Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA Foreign: Belgium, Canada, Germany, Hungary, Luxemburg, Malaysia, Mexico, Poland, Slovakia, South Africa, South Korea, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |