FDA Medical Device Recalls (openFDA)
Datascope Corporation: SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
- Recall number
- Z-2164-2017
- Recalling firm
- Datascope Corporation
- Product
- SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
- Status
- Terminated
- Initiated
- 2017-04-12
- Posted
- not on file
- Terminated
- 2020-01-28
- Reason
- Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since during internal pressure (leak) testing of the SENSATION PLUS 8Fr. 50cc, IABC, failures related to the tip seal leak were identified.
- Root cause
- Device Design
- Action
- Getinge notified their customers with a recall letter/return response form via Fed Ex on 4/12/2017. Getinge notified their customers again through an expansion on 10/16/2017.
- Quantity
- 996 UNITS
- Distribution
- Nationwide
- Lot, serial or model codes
- 300004515, 3000043376 3000040272 3000038372 added lot numbers: 3000043374 and 3000045513
- 510(k) numbers
- ["K133074"]
- 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