FDA Medical Device Recalls (openFDA)
Datascope Corp.: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Recall number
- Z-2616-2021
- Recalling firm
- Datascope Corp.
- Product
- Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Status
- Open, Classified
- Initiated
- 2021-09-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
- Root cause
- Software design
- Action
- On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid experience the following issue: Unexpected Shutdown Upon Battery Removal. Immediate Actions to be taken by Customers: To ensure that the Cardiosave Hybrid is not susceptible to shutdown during the removal of a battery, users should not eject a battery when: - There is a singulat battery in either battery charging bay and unused battery bay is empty. - The battery is charging on AC power (indicated by a flashing LED on the battery pack). Additionally, the user can prevent the issue by ensuring that a battery is inserted into each of the two battery bays. Should a charging battery be ejected inadvertently, the unit will automatically switch over to the second battery, thus preventing system shutdown. Furthermore, Datascope/Getinge is developing a software correction to address this issue. A Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Quantity
- 3969 total (US); 3550 total (OUS)
- Distribution
- Nationwide domestic distribution. Foreign distribution worldwide.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K181122"]
- PMA numbers
- not on file
- Product code
- DSP
- Firm FEI
- 3001418283
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28