FDA announces new IABP recall after 4 serious injuries, 1 death
The U.S. Food and Drug Administration (FDA) has announced that Datascope, a subsidiary of Getinge, is recalling two different Cardiosave intra-aortic balloon pumps (IABPs) due to a risk of blood entering the device through a damaged catheter. There have been 134 incidents so far due to this issue, including 12 device shutdowns, four serious injuries and one patient death.
The recall covers both the Cardiosave Hybrid IABP and the Cardiosave Rescue IABP. A total of 4,454 devices are included.
Blood entering the IABP during treatment can cause multiple issues, according to the FDA’s advisory. It can cause the IABP to shutdown unexpectedly, for instance, or patients could have helium released into their blood, which can damage the brain and other organs. In addition, clinicians and any other personnel interacting with the device after the procedure could potentially be exposed to an “unexpected biohazard.”
The FDA emphasized that clinicians who encounter this problem should not bypass any device alarms.
“Pay close attention to alarm notifications as that may help identify a perforated balloon earlier and prevent blood from traveling into the IABP,” the advisory reads. Such notifications include those that may say “Autofill Failure,” “Autofill Failure—Blood Suspected,” “Gas Gain in IAB Circuit,” “Gas Loss in IAB Circuit” and “IAB Catheter Restriction.”
If any blood is detected—or damage to the device is confirmed—clinicians are advised to follow the following steps immediately:
- Stop pumping by placing IABP console in standby.
- Disconnect the catheter extender tubing from the IABP console to allow the balloon to deflate.
- Clamp extracorporeal tubing between white y-fitting and male connector.
- Place the patient in Trendelenburg as tolerated to guide any residual helium to travel away from the head vessels.
- Notify physician and prepare for IAB catheter removal.
- Consider IAB catheter replacement if the patient's condition warrants.
If it is believed that blood did enter the pump, the device should be immediately taken out of service, the FDA added. It should then be evaluated to see if any parts need to be replaced due to contamination.
Additional information from the FDA is available here. Also, click here to read about a related recall from December 2021.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.