Z-2164-2017Class II

SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part...

Name: Z-2164-2017 SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part...
Creator: Datascope Corporation
Published: 2017-04-12
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-04-12 / Terminated / root cause: design

FDA source

Datascope Corporation began a recall of 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... on 2017-04-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2164-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-12
Posted: 2018-10-11
Terminated: 2020-01-28
Recalling firm: Datascope Corp.
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.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: 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 tag: design
FDA 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 in commerce: 996 UNITS
Distribution: Nationwide
Product codes and lots: 300004515, 3000043376 3000040272 3000038372 added lot numbers: 3000043374 and 3000045513

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2164-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2164-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-25

Product code DSP

K133074Class IIMega 8Fr. 50Cc and Sensation Plus 8Fr. 50Cc Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp. / cleared 2013-12-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)