Search
Type
Audience
Category
Issue
Last updated
Recall class
Please note: using the search filters may not provide accurate search results for records prior to November 2021. When searching for older records, please ensure that you use the include archive checkbox.
Displaying 1 - 4 of 4 items.
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
While conducting safety disk testing, expired tubing was used on the test fixture equipment between April 01, 2022 and July 31, 2022. when using the obsoleted, and expired catheter extender tube, 0004-00-0033-01 during the static inflate/deflate test…
RecallHealth product recall | 2023-03-16
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
There is a potential for the following 4 issues to occur: 1. unexpected shutdown due to failure of the connection with the coiled cable cord (serial numbers specific); 2. unexpected shutdown due to loss of communication between the executive processor…
RecallHealth product recall | 2023-02-17
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
Datascope/Getinge has received complaints reporting unexpected shutdown of the Cardiosave IABP while providing therapy in very rare instances. An internal investigation of the complaints determined an unexpected shutdown may be due to blood…
RecallHealth product recall | 2023-01-04
Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump
The exterior of the cardiosave hybrid and rescue IABP may be susceptible to fluid ingress at specific locations on the device. IABPs contain various electronic circuit boards. Liquid spills, such as saline, can create bridges of resistance between the…
RecallHealth product recall | 2021-12-13