Recall Z-0290-2024 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Medical Systems USA
Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
| Date | Nov 9, 2023 (initiated Oct 12, 2023) |
| Status | Open, Classified |
| Reason | It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force. |
| Root cause | Device Design |
| Action | An URGENT MEDICAL DEVICE Correction notification letter dated 10/12/23 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received a CARDIOHELP-i System having a serial number that is affected by this voluntary Medical Device Correction. " Please examine your inventory immediately to determine if you have any affected CARDIOHELP System(s) in your inventory. " Should you have any affected CARDIOHELP-i System(s), your unit(s) will need to be returned to Getinge for correction. Getinge will contact your facility to arrange the return of your unit for |
| Quantity | 1022 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |