Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (eg, inadequate blood supply or a vital organ injury), and death,” the US Food and Drug Administration (FDA) says in the recall notice.
The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.
The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.
The recall includes a total of 4586 CardioSave Hybrid or Rescue IABP units distributed from Marcy 2, 2012 to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.
On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 AM and 6:00 PM ET.
History of Trouble
Last March, Datascope/Getinge recalled 2300 Cardiosave Hybrid or Rescue 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, as reported by theheart.org | Medscape Cardiology.
The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks .
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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