Datascope Corp.: Medical Device Recall in 2023 - (Recall #: Z-2432-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Product Classification:
Class I
Date Initiated: July 31, 2023
Date Posted: September 6, 2023
Recall Number: Z-2432-2023
Event ID: 92501
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.
Status: Ongoing
Product Quantity: 9175 units
Code Information:
All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Distribution Pattern:
Worldwide - US Nationwide distribution.
Voluntary or Mandated:
Voluntary: Firm initiated