Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

The latest Class I recall for these beleaguered devices relates to communication loss between circuit board assembly units.

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Another week, another recall for the beleaguered Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) manufactured by Getinge/Datascope—this time due to a “communication loss” between the executive processor printed circuit board assembly (PCBA) and the video generator PCBA that can lead to pump shutdown.

The US Food and Drug Administration, categorizing the recall as Class I—the most serious type—issued this latest bulletin March 31, 2023. Getinge/Datascope had earlier sent an “urgent medical device correction” to consumers as part of a list of other notifications back in early February.

According to today’s FDA bulletin, a shutdown stemming from this form of communication loss “will occur without warnings or alarms to alert the user. Once the error occurs, one or both of the PCBAs will need to be replaced for the device to work again.”

Hemodynamic instability resulting from a shutdown can lead to organ damage and/or death, the FDA warns. So far, the manufacturer has received 42 complaints of unexpected shutdowns related to PCBA communication failures, but no reports of injuries or deaths.

Over 4,500 units distributed between March 6, 2012, and January 13, 2023, are affected by the recall. Users are advised to swap out the IABP for another if shutdown occurs, and if the device remains inoperable following shutdown, to remove it from patient care. The company has developed a software patch to correct the problem and is reaching out to customers to schedule installation.

Just last week, the FDA alerted users about a different cause for unexpected shutdown with certain Cardiosave pumps, that time involving the failure of a coiled cable connecting the display and the base. Back in January, a recall for these same devices cited a “blood back event” in which damage to the balloon catheter might permit blood to flow back into the pump.

Problems with Cardiosave IABP devices have become regular fodder for FDA recall notices including bulletins related to fluid leaks and battery problems in 2021, battery failures in 2019, possible failure at high altitudes in 2018, fluid ingress problems in 2018 and 2017, and potential electrical test failures and valve failures back in 2017.

Shelley Wood is Managing Editor of TCTMD and the Editorial Director at CRF. She did her undergraduate degree at McGill…

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