Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part… recallZ-2431-2023 · Datascope Corp. · initiated Jul 31, 2023

Why it was recalled

Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.

FDA root cause category: Under Investigation by firm

What the company is doing

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Docking/Power Battery Failure 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. The Cardiosave device has two operating modes: Hybrid (docked within the hospital cart) and Rescue (transport). When in Hybrid mode the IABP may operate on both AC power and battery power; and when plugged in (AC power) can charge inserted batteries. When in Rescue (transport) mode, the IABP can operate on battery power, or AC Power with the use of the Transport Power Supply accessory (occupying a battery bay). However, unless the Cardiosave is powered off, the Transport Power Supply will not charge a battery inserted into the alternate battery bay unless the Transport Power Supply is connected directly to AC power. There are two methods where the IABP can be in transport/rescue mode without user intent: 1) The Cardiosave Hospital Cart's release latch has been released and the IABP console is not properly installed in the cart. 2) The IABP console is inserted into the hospital cart, but is not fully latched into the cart In both cases, information is provided to the user that the system is not in Hybrid mode via the Rescue Mode Icon on the bottom Cardiosave screen (top center of the screen). In addition, the battery in use message will be displayed in the informational message area even if the AC power cord is plugged in. Additionally, in both scenarios, the Cardiosave will not receive AC power and if the device is in operation, it will continue to operate on battery. When the Cardiosave is not receiving AC power, the batteries are unable to charge. If the AC Plug Icon is not present and/or the Rescue Icon is present, release the latch on the Hospital Cart located b

Recall details

Recall number

Z-2431-2023

Status

Open, Classified

Initiated by the company

Jul 31, 2023

Posted by the FDA

Aug 30, 2023

Recalling firm

Datascope Corp.

Quantity

9175 units

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

Devices named in this recall

13 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

Other products in the same recall event

The FDA groups related products into one recall event (event 92501).

• Z-2432-2023 · Open, Classified
  Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85