Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85

Recall number

Z-2434-2023

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, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,

Status

Open, Classified

Initiated

2023-07-31

Posted

2023-08-30

Terminated

not on file

Reason

Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.

Root cause

Device Design

Action

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. System Over-Temperature 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. When a System Over Temperature alarm is triggered, the device must be powered down andallowed to cool to a safe operating internal temperature before therapy can be re-initiated using the same IABP.Should you experience a System Over Temperature of Cardiosave IABP during therapy, perform the following instructions documented in CARDIOSAVE Hybrid and Rescue, Operational Instruction for US and OUS: 1. Turn the IABP OFF by pressing and holding the green IABP Power Button, located on theback panel, for 2 seconds 2. Wait 10 seconds 3. Turn the IABP ON by pressing and releasing the green IABP Power Button If the alarm message persists, switch to another IABP if available and contact your Service representative. If another IABP console is not available for use, alternative means of providing hemodynamic support (vasopressors, inotropes or alternate therapies) may be initiated by a healthcare provider as a temporizing measure. Consideration should be given to having a backup IABP available in the event the IABP doesn t cool sufficiently to restart or the alarm reoccurs. To help prevent such alarms from occurring, ensure that there are no restrictions to the airflow around the Cardiosave device. Restrictions to the vents on the device can significantly increase the internal temperature of the device, leading to such temperature excursions. Additionally, as per CARDIOSAVE Hybrid and Rescue Operational Instruction, it is essential not to operate the Cardiosave device outside of the posted operating ambient ranges. This is to prevent such temperature excursions and ensure the safe and effe

Quantity

47 units (42 US, 5 OUS)

Distribution

Worldwide - US Nationwide distribution.

Lot, serial or model codes

All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449, Model: 0998-UC-0800-75, UDI: N/A; Model: 0998-UC-0800-83, UDI: N/A; Model: 0998-UC-0800-85, UDI: N/A;

510(k) numbers

K181122

PMA numbers

not on file

Product code

DSP

Firm FEI

3001418283

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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