Z-1062-2015Class II

CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human...

Name: Z-1062-2015 CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human...
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2014-12-16
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2014-12-16 / Terminated / root cause: design

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration... on 2014-12-16. FDA classified it as Class II and gives the reason as "Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit...". 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-1062-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-16
Posted: 2015-02-07
Terminated: 2017-06-09
Recalling firm: Datascope Corp.
Product: CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.
Root cause tag: design
FDA root cause: Device Design
Action: Maquet Inc. sent a Product Recall Medical Device Field Correction letter/Field Correction response form, dated 12/16/2014 via Fed Ex. The letter identified the affected product and the reason for the recall. Users were asked to inspect their inventory for the affected units. If customers have any affected product, they are to follow the instructions provided. Additionally, users are to complete and return the attached Field Correction Response Form to acknowledge receipt of the letter and to indicate completion of the steps outlined. Completed forms should be returned by e-mailing a scanned copy to [email protected] or faxing a copy to 1-973-396-3607. Technical questions should be directed to the Technical Support Department at 1-800-777-4222.
Quantity in commerce: 838 units-US; 364 units - OUS
Distribution: Worldwide Distribution
Product codes and lots: Sensation 7 fr.34 cc IAB Demonstration Unit 0684-DC-0433 0684-DO-0433 0684-DC-0469 0684-DO-0469 Sensation 7 Fr. 40 cc IAB Demonstration Unit 0684-DC-0434 0684-DO-0434 0684-DC-0470 0684-DO-0470 Sesnsation Plus 7.5 Fr. 40cc IAB Demonstration Units 0684-DC-0567 0684-DO-0567 0684-DC-0568 0684-DO-0568 Sensation Plus 7.5 Fr. 50cc IAB Demonstration Units 0684-DC-0575 0684-DO-0575 0684-DC-0576 0684-DO-0576 Sensation Plus 8 Fr. 50 cc IAB Demonstration Unit 0684-DC-0272 0684-DO-0272

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1062-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1062-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-18	2015-02-06

Product code DSP

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)