LVAD obstruction linked to 14 deaths; FDA designates recall as class I
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Key takeaways:
- The FDA designated Abbott/Thoratec Corp’s recall of two LVADs as class I, the most serious type.
- Long-term use may result in extrinsic outflow graft obstruction caused by biological material buildup.
Abbott/Thoratec Corp. issued a recall of two of its left ventricular assist devices due to risk for obstruction from the long-term buildup of biological material during use.
There have been 273 injuries and 14 deaths related to the issue, according to an alert from the FDA.
The FDA has identified the recall of the LVADs (HeartMate II and HeartMate 3) as a class I recall, the most serious type of recall, as use of the devices may cause serious injury or death. The FDA stated this recall is a correction, not a product removal.
Device obstruction, called extrinsic outflow graft obstruction, typically occurs over 2 or more years of use and reduces the ability of the LVAD pump blood, triggering low blood flow alarms, according to the alert.
The recall includes 13,883 devices distributed since April 21, 2008.
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