Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

FDA device recall Z-2432-2023 · posted 2023-08-30 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

Reason for recall

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DSP

Quantity affected

9175 units

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2023-07-31

Date posted

2023-08-30

Location

Mahwah, NJ

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