Z-2437-2023Class I

Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31...

Name: Z-2437-2023 Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31...
Creator: Datascope Corp.
Published: 2023-07-31
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2023-07-31 / Open, Classified

FDA source

Datascope Corp. began a recall of Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33... on 2023-07-31. FDA classified it as Class I and gives the reason as "Users were identifying autofill failure conditions on the devices causing pump stops". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2437-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-07-31
Posted: 2023-08-30
Recalling firm: Datascope Corp.
Product: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Users were identifying autofill failure conditions on the devices causing pump stops.
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE CORRECTION dated 7/31/23 was sent to customers. Autofill Alarms User Actions to be taken now: Our records indicate that you may have a Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. As a result of the investigation into the complaints, Getinge would like to reinforce information that is detailed in the Cardiosave Instructions for Use to help minimize the frequency and impact of these alarms: As per the Cardiosave Operating Instructions in sections 2.1.8, Initiation of Assist and 2.1.9, IAB Fill ; the system performs an autofill under the following three conditions: " Initiation of Therapy " Every two (2) hours while therapy is ongoing " If during transport, the atmospheric pressure changes by a 25 mmHg (~1,000 ft.) rise or 50 mmHg (~2,000 ft.) drop during therapy to keep the balloon pressure acclimated to local conditions If the autofill procedure fails to purge and fill the Pneumatic Module properly, the message Autofill Failure will be displayed, an audible alarm will be activated, and pumping will be suspended until the alarm is cleared. Corrective action can be obtained by pressing the Help Available key. The three high priority alarms are: " Autofill Failure No Helium " Autofill Failure Blood Suspected " Autofill Failure Note: Autofill Failure Blood Suspected is caused by a leak in the IAB which results in blood migration back into the IABP system. The failure of the IAB is outside of the scope of this Field Safety Notification. Autofill Failure No Helium " Verify that the Cardiosave device has sufficient Helium in the system. " If the Cardiosave is in Hybrid mode (console within a hospital cart), verify the external Helium Tank is connected to the cart, is opened, and there is sufficient Helium in the tank to support the IABP therapy. " If the Cardiosave is in Rescue
Quantity in commerce: 9175 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: All Lot Numbers. Model: 0998-00-0800-31, UDI: 10607567109053; Model: 0998-UC-0800-31, UDI: N/A; Model: 0998-00-0800-32, UDI: 10607567111117; Model: 0998-00-0800-33, UDI: 10607567109008; Model: 0998-UC-0800-33, UDI: N/A; Model: 0998-00-0800-34, UDI: 10607567111940; Model: 0998-00-0800-35, UDI: 10607567109107; Model: 0998-00-0800-45, UDI: 10607567108421; Model: 0998-00-0800-52, UDI: 10607567108438; Model: 0998-UC-0800-52, UDI: N/A; Model: 0998-00-0800-53, UDI: 10607567108391; Model: 0998-UC-0800-53, UDI: N/A; Model: 0998-00-0800-55, UDI: 10607567108414; Model: 0998-UC-0800-55, UDI: N/A; Model: 0998-00-0800-65, UDI: 10607567113432; Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2437-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2437-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-30
Z-2438-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-30

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)