Recall Z-2736-2017 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Datascope Corp - Cardiac Assist Division
CS 100i Intra-Aortic Balloon Pump
| Date | Jun 23, 2017 (initiated Jun 16, 2017) |
| Status | Terminated |
| Reason | The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. |
| Root cause | Component design/selection |
| Action | Datascope Corp/MAQUET issued a press release on June 16, 2017. Datascope Corp/MAQUET sent an Urgent Product Recall Letter on June 19, 2017, to their customers via FedEx next day delivery service. Pursuant to the WARNINGS section of our CS100i, CS100 or CS300 IABP Operating/User Instructions, clinicians are instructed not to leave the patient unattended during IABP therapy. Until the service is performed, we recommend the IABP be powered on prior to initiation of therapy to allow the IABP to successfully complete its self-test. This action will take less than 60 seconds to perform. In the e |
| Quantity | 12,319 units total |
| Distribution | Worldwide Distribution - (in over 100 countries) US (Nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031636 | CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX Datascope Corp., Aug 11, 2003 |