Z-3135-2024Class I

CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate...

Name: Z-3135-2024 CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate...
Creator: Datascope Corp.
Published: 2024-08-08
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2024-08-08 / Open, Classified / root cause: software

FDA source

Datascope Corp. began a recall of CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons on 2024-08-08. FDA classified it as Class I and gives the reason as "Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-3135-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-08-08
Posted: 2024-09-20
Recalling firm: Datascope Corp.
Product: CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were mailed an URGENT FIELD SAFETY NOTICE dated 8/5/2024. This notification informs consignees of the deployment of previously installed software to mitigate previously identified issues in Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump devices. Consignees are asked to examine their inventory immediately to identify if they have any Cardiosave Hybrid and/or Rescue IABP devices, and to identify what software version is currently installed in devices. Devices with software revision D.00 or D.01 have been corrected. If consignee units have a software version lower than D.00 or D.01 (e.g.: B.XX or C.XX) the device still requires the software update and has not yet been corrected. If consignee units do not have the corrected software revision installed, they are to continue to follow the instructions as listed int he original recall notification until the affected device(s) has been updated. Consignees are to complete and return the provided Response Form to the provided email address. Datascope/Getinge service representatives will contact consignees to schedule installation of software, if needed. Consignees are to forward the recall notice to all device users in their facility and to any customers to whom the device was shipped.
Quantity in commerce: 5,475 units
Distribution: International distribution to the countries of UNITED ARAB EMIRATES, ARGENTINA , AUSTRIA, AUSTRALIA, BELGIUM, BULGARIA, BAHRAIN, BRAZIL, CANADA, SWITZERLAND, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, GERMANY, DENMARK, ECUADOR, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, INDONESIA, IRELAND, INDIA, IRAQ, IRAN, ITALY, JORDAN, JAPAN, SOUTH KOREA, KUWAIT, LEBANON, LITHUANIA, LIBYA, MOROCCO, MYANMAR, MEXICO, MALAYSIA, NETHERLANDS, NORWAY, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PALESTINE, PORTUGAL, SERBIA, RUSSIAN FEDERATION, SAUDI ARABIA, SWEDEN, SINGAPORE, SLOVAKIA, THAILAND, TURKEY, TAIWAN, UNITED KINGDOM, VIETNAM, YEMEN.
Product codes and lots: Product No. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85; UDI: 10607567112312, 10607567108407, 10607567113449; Lot No. ALL LOTS.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3135-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3134-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20
Z-3135-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)