Datascope/Getinge is recalling certain Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.
The U.S. Food and Drug Administration has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.
The FDA warns that an unexpected pump shutdown and any interruption to therapy that occurs can lead to hemodynamic instability, organ damage, and/or death, especially in patients who are critically ill and most likely to receive therapy using these devices.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
From June 2019 to August 2022, Datascope/Getinge reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths related to this issue, according to the recall notice posted on the FDA’s website.
The recall includes a total of 2,300 CardioSave Hybrid or Rescue IABP units distributed prior to July 24, 2017, and/or coiled cord part number 0012-00-1801. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
The Cardiosave IABPs have previously been flagged by the FDA for subpar battery performance and fluid leaks.
To address the cable issue, Datascope/Getinge sent an urgent medical device correction letter to customers recommending that the coiled cable cord of the Cardiosave IABP be inspected for visible damage prior to use.
If an unexpected shutdown occurs, an attempt should be made to restart the Cardiosave IABP until an alternative pump is available. If the restart attempt is unsuccessful, an alternative IABP should be used. Any device that remains inoperable after a shutdown should be removed from patient care.
Customers should inspect their inventory to identify any Cardiosave Hybrid and/or Rescue IABPs that have the recalled coiled cord.
The company also asks customers to complete and sign the Medical Device Correction-Response form included with the letter and return it to Datascope/Getinge by emailing a scanned copy to email@example.com or by faxing the form to 1-877-660-5841.
Customers with questions about this recall should contact their Datascope/Getinge representative or call Datascope/Getinge technical support at 1-888-943-8872, Monday through Friday, between 8:00 AM and 6:00 PM ET.
The company has developed a hardware correction to address this issue and says a service representative will contact customers to schedule installation of the correction when the correction kit is available.
Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
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