Balloon Pump Recall: Fan Assembly Failure
Datascope Corp/MAQUET has issued a voluntarily recall for 12,360 affected intra-aortic balloon pumps.
About the Balloon Pump Recall
The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate an intra-aortic balloon to provide support to the left ventricle through counter pulsation.
According to the U.S. Food and Drug Administration (FDA), certain brand name balloon pumps possess potential mechanical failures of the fan assembly associated with the power supply.
It’s possible that the failure of the fan could cause the power supply to overheat and shut down the IABP without warning users.
Customers who have purchased the recalled balloon pumps have been notified. MAQUET services should contact facilities with affected IABPs to fix the problem.
Description of Recalled IABPs
The IABPs being recalled are sold under the Datascope Corp. System and possess the following system and part numbers:
- System 98/98XT
- System CS100/CS100i
- System CS300
When the IABP shuts down, it could result in worsened heart failure, decreased blood to the heart, and/or decreased blood flow to the body and brain.
The FDA has classified this recall as a Class 1 recall because the malfunctions of this product could cause serious health consequences or death.