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Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part… recallZ-2434-2023 · Datascope Corp. · initiated Jul 31, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Datascope Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-2434-2023
Status
Open, Classified
Initiated by the company
Jul 31, 2023
Posted by the FDA
Aug 30, 2023
Recalling firm
Datascope Corp.
Quantity
47 units (42 US, 5 OUS)
Product code
DSP
FDA submissions
K181122
Distribution
Worldwide - US Nationwide distribution.

Product description

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,

Code information (models, lots, serial numbers)

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;

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 92498).

Sources and updates

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