Z-1198-2009

Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon...

Name: Z-1198-2009 Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon...
Creator: Datascope Corporation
Published: 2009-02-04
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2009-02-04 / Terminated / root cause: manufacturing process

FDA source

Datascope Corporation began a recall of 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... on 2009-02-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1198-2009
Status: Terminated
Initiated: 2009-02-04
Posted: 2009-04-15
Terminated: 2009-08-11
Recalling firm: Datascope Corp.
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.
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 20
Distribution: Nationwide Distribution -- states of IL and FL.
Product codes and lots: Part Number: 0012-00-1589-03 Rev. C, RAM 0827.

Product code DSP

K063525Class IIDatascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and Cs300 Intra-Aortic Balloon Pump Control SystemDatascope Corp. / cleared 2007-01-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)