The FDA has issued an early alert regarding certain Abiomed Impella system components after the company recommended removing specific products from use because of an increased risk of purge leaks.
In a Feb. 18 letter to customers, Abiomed said it is removing Generation 1 Impella Purge Cassettes in markets where Generation 2 versions are available. The FDA followed with an early alert Feb. 25, citing the potentially high-risk nature of the device issue.
The affected products include Generation 1 Purge Cassettes packaged within Impella RP US Pump Sets (product code 004334) and Purge Cassette five-packs (product code 0043-0003).
According to Abiomed, the Generation 1 cassettes carry an increased risk of purge leaks. If a leak occurs, users may see a “Purge Pressure Low” alarm on the Automated Impella Controller. If not addressed, the issue could lead to low purge pressure, biomaterial ingress and an unexpected pump stop, potentially resulting in loss of hemodynamic support and patient death.
As of Feb. 3, Abiomed reported four serious injuries associated with the issue.
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