Z-1248-2016Class II

Cardiosave Hybrid and rescue IABP

Name: Z-1248-2016 Cardiosave Hybrid and rescue IABP
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2015-12-16
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2015-12-16 / Terminated

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of Cardiosave Hybrid and rescue IABP on 2015-12-16. FDA classified it as Class II and gives the reason as "Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1248-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-16
Posted: 2016-03-25
Terminated: 2018-06-01
Recalling firm: Datascope Corp.
Product: Cardiosave Hybrid and rescue IABP
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
FDA root cause: Other
Action: Maquet sent an "Urgent - Medical Device Field Correction Notice and Response form dated December 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed of the issues and provided corrective actions. Customers are asked to completed the attached response form in order to return to 1-973-629-1518, or via email to [email protected]. Questions can be directed 1-800-777-4222, option 3, Monday through Friday 8 am-6 pm. EST.
Quantity in commerce: 1243 units US; 1107 units OUS
Distribution: Worldwide Distribution- Nationwide Distribution including Puerto Rico.
Product codes and lots: Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1248-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1248-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-25

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)