Z-0099-2019Class I

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Name: Z-0099-2019 Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Creator: Maquet Datascope Corp - Cardiac Assist Division
Published: 2018-09-20
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2018-09-20 / Open, Classified / root cause: design

FDA source

Maquet Datascope Corp - Cardiac Assist Division began a recall of Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 on 2018-09-20. FDA classified it as Class I and gives the reason as "There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0099-2019
Classification: Class I
Status: Open, Classified
Initiated: 2018-09-20
Posted: 2018-10-27
Recalling firm: Datascope Corp.
Product: Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.
Root cause tag: design
FDA root cause: Device Design
Action: On September 20, 2018, Maquet/Getinge issued a press release. On September 24, 2018 and on September 28, 2018, Maquet/Getinge issued URGENT MEDICAL DEVICE CORRECTION notices along with an Instructions for Use Addendum to customers. On October 23, 2018 a modified version of the Urgent Medical Device Correction Letter and response form was sent to 23 new U.S. consignees who received Cardiosave IABP devices after the ship-hold was released. The post ship-hold devices contain the IFU addendum. This modified version of the letter notifies customers of the altitude issue and the required software update. Maquet/Getinge is currently developing a software correction to address this issue. Customers are encouraged to use the following items as specified according to altitude levels: Sensation 34cc / 40cc (Balloon Name and Size) Sensation Plus 40cc / 50cc (Balloon Name and Size) Operating Altitude: -1250 feet to 3,200 feet (795 mmHg to 676 mmHg) (1060 hPa to 901 hPa) Mega 50cc (Balloon Name & Size) Operating Altitude: -1250 feet to 5000 feet (795 mmHg to 632 mmHg) (1060 hPa to 843 hPa) Mega 30cc / 40cc (Balloon Name & Size) Linear 25cc / 34cc / 40cc (Balloon Name & Size) Operating Altitude: -1250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1060 hPa to 644 hPa) For technical questions, please contact Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST
Distribution: US Nationwide; Internationally to 77 countries
Product codes and lots: UDI - 10607567108391 All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0099-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0099-2019	Class I	Ongoing	Voluntary: Firm initiated	2018-11-07	2018-10-26
Z-0100-2019	Class I	Ongoing	Voluntary: Firm initiated	2018-11-07	2018-10-26

Product code DSP

K181122Class IICARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. / cleared 2018-05-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)