Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to
FDA device recall Z-1198-2009 · posted 2009-04-15 · Terminated
Recall details
- Recalling firm
- Datascope Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 20
- Distribution
- Nationwide Distribution -- states of IL and FL.
- Date initiated
- 2009-02-04
- Date posted
- 2009-04-15
- Date terminated
- 2009-08-11
- Location
- Fairfield, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM (K063525) | Datascope Corp. | 2007-01-05 |