Z-1140-2015Class II

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

Name: Z-1140-2015 Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2015-01-30
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2015-01-30 / Terminated

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) on 2015-01-30. FDA classified it as Class II and gives the reason as "Power supply malfunction complaints related to suboptimal thermal management". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1140-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-30
Posted: 2015-02-23
Terminated: 2017-09-29
Recalling firm: Datascope Corp.
Product: Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Power supply malfunction complaints related to suboptimal thermal management.
FDA root cause: Under Investigation by firm
Action: Maquet Inc. sent a recall letter/return response form dated 1/30/2015.
Quantity in commerce: 1,300 units
Distribution: US Nationwide distribution
Product codes and lots: 0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55. CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1140-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1140-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-23

Product code DSP

K112372Class IICardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC / cleared 2011-09-15

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)