FDA Medical Device Recalls (openFDA)
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 number
- Z-1198-2009
- Recalling firm
- Datascope Corporation
- 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.
- Status
- Terminated
- Initiated
- 2009-02-04
- Posted
- 2009-04-15
- Terminated
- 2009-08-11
- 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.
- Lot, serial or model codes
- Part Number: 0012-00-1589-03 Rev. C, RAM 0827.
- 510(k) numbers
- ["K063525"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 1000222374
- Firm city
- Fairfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28