Recall Z-1198-2009 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corporation
Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
| Date | Apr 15, 2009 (initiated Feb 4, 2009) |
| Status | Terminated |
| Reason | Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor. |
| Root cause | Process design |
| Action | An "Urgent Medical Device Recall" letter dated February 4, 2009 was delivered to affected consignees by Datascope Field Representatives. Direct questions to your local Sales/Service Representative or call the Datascope Corporation at 1-973-244-6314. |
| Quantity | 20 |
| Distribution | Nationwide Distribution -- states of IL and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063525 | DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM Datascope Corp., Jan 5, 2007 |