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.
FDA Recall Z-1198-2009 · Posted 2009-04-15
Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeDSP
Date Initiated2009-02-04
Date Terminated2009-08-11
Product Quantity20
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.
Firm 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.
Root Cause
Process design
Distribution Pattern
Nationwide Distribution -- states of IL and FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.