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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Datascope Corporation
Lot Codes / Batch Numbers
Part Number: 0012-00-1589-03 Rev. C, RAM 0827.
Products Sold
Part Number: 0012-00-1589-03 Rev. C, RAM 0827.
Datascope Corporation is recalling Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic b due to Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026