Z-2486-2023Class II

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

Name: Z-2486-2023 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 II and gives the reason as "Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2486-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-31
Posted: 2023-08-31
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 experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Fiber Optic Damage 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. Fiber optics assists in the rapid acquisition and accuracy of the arterial pressure waveform although it is not required to provide therapy with a fiber optic catheter. As detailed within the IFU and educational guides, the patient s arterial pressure can also be obtained via the catheter s inner lumen by connecting a standard fluid-filled pressure bag system or by connecting an external arterial pressure source (typically a radial or femoral arterial line) to the IABP console. Despite the ability of using fiber optics for pressure monitoring, the IFU continues to advise maintenance of the catheter s inner lumen. This guidance is provided within the IFU and Operating guides to both prevent thrombus formation at the end of the catheter, as well as to maintain the integrity of the inner lumen despite the use of the fiber optic signal for monitoring. This provides an alternative source for guiding the therapy if the fiber optic signal is lost. Using AUTO Mode and the ECG as Trigger If in Semi-AUTO MODE and using the fiber optic signal as the trigger source and the signal is not available, utilizing AUTO mode will automatically select the ECG or other available trigger source to guide therapy. When in AUTO mode should the fiber optic signal be lost, therapy can still be safely delivered using only the ECG. However, should the ECG not be a reliable or accurate signal, and the system seeks the arterial signal to guide therapy, the IABP will not have the information needed to guide therapy, and therapy is stopped. Should no alternative arterial pressure source be available, the hospital
Quantity in commerce: 9379 units
Distribution: US Nationwide. Global 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-2486-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2486-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-30
Z-2487-2023	Class II	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)