Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part… recallZ-2433-2023 · Datascope Corp. · initiated Jul 31, 2023

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-2433-2023

Status

Open, Classified

Initiated by the company

Jul 31, 2023

Posted by the FDA

Aug 30, 2023

Recalling firm

Datascope Corp.

Quantity

11574 units (5413 US, 6161 OUS)

Product code

DSP

FDA submissions

K181122

Distribution

Worldwide - US Nationwide distribution.

Product description

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, 0998-00-0800-36, 0998-UC-0800-32, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-65,

Devices named in this recall

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

• CARDIOSAVE HYBRID, TYPE B PLUG 0998-00-0800-53

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls39 deaths10,316 reports
• CARDIOSAVE HYBRID W/ E/F PLUG 0998-00-0800-55

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls8 deaths1,686 reports
• CARDIOSAVE HYBRID, TYPE I PLUG 0998-00-0800-45

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls5 deaths1,181 reports
• CARDIOSAVE HYBRID, TYPE G PLUG 0998-00-0800-52

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls2 deaths1,157 reports
• CARDIOSAVE RESCUE 0998-00-0800-83

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  26 recalls167 reports
• CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  20 recalls3 deaths456 reports
• CARDIOSAVE HYBRID TYPE I (AU) 0998-00-0800-31

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls232 reports
• CARDIOSAVE HYBRID TYPE D PLUG 0998-00-0800-33

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls2 deaths230 reports
• CARDIOSAVE HYBRID TYPE J PLUG 0998-00-0800-32

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls2 deaths48 reports
• CARDIOSAVE RESCUE, CHINESE 0998-00-0800-75

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls12 reports
• CARDIOSAVE RESCUE, 3.1 EDITION 0998-00-0800-85

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  21 recalls1 report
• CARDIOSAVE HYBRID TYPE M PLUG 0998-00-0800-35

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  19 recalls13 reports
• CARDIOSAVE HYBRID TYPE K PLUG 0998-00-0800-34

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  15 recalls0 reports
• CARDIOSAVE HYBRID - TYPE "N" PLUG 0998-00-0800-36

  Datascope Corp. · System, Balloon, Intra-Aortic And Control
  9 recalls1 death16 reports

Other products in the same recall event

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

• Z-2434-2023 · Open, Classified
  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,