Z-2436-2023Class I

Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83...

Name: Z-2436-2023 Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83...
Creator: Datascope Corp.
Published: 2023-07-31
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2023-07-31 / Open, Classified / root cause: labeling and UDI

FDA source

Datascope Corp. began a recall of Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 on 2023-07-31. FDA classified it as Class I and gives the reason as "Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2436-2023
Classification: Class I
Status: Open, Classified
Initiated: 2023-07-31
Posted: 2023-08-30
Recalling firm: Datascope Corp.
Product: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Product code: DSP System, Balloon, Intra-Aortic And Control
Reason for recall: Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Gas Loss & Gas Gain 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) affected by this correction in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. The following actions should be taken should you experience an alarm for Gas Loss in IAB & Gas Gain in IAB : Gas Gain in IAB Circuit " Verify all of the tubing connections are leak free. " Press the START key to initiate an Autofill and resume pumping. Gas Loss in IAB Circuit " Inspect the tubing from the patient through to the connection of the helium extender tubing to the female luer port of the Cardiosave IABP. " If any blood is noted or perforation is suspected, the following procedure must be performed immediately: 1. Disconnect the catheter extender tubing from the IABP console to allow the balloon to deflate. 2. Clamp extracorporeal tubing between white y-fitting and male connector. 3. Place patient in Trendelenburg as tolerated to guide any residual helium to travel away from the head vessels. 4. Notify physician, and prepare for IAB catheter removal. 5. Consider IAB catheter replacement, if the patient s condition warrants. 6. If blood is suspected of having entered the pump, take pump out of service. It should be evaluated before use in another patient by a Getinge or Biomed/Technical Service representative who has been trained on Cardiosave service requirements, to determine if replacement of contaminated components is necessary. " If blood is not detected, ensure that the IAB extender tubing is tightly connected to the IAB and the IABP. If appropriate, perform an Autofill by pressing and holding the IAB FILL key for 2 seconds, then press the START key to resume pumping. " If the patient is febrile or tachycardic, consider increasi
Quantity in commerce: 9175 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: All Lot Numbers. 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-2436-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2435-2023	Class I	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-30
Z-2436-2023	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)