FDA Issues Early Alert On Abiomed Heart Pump Controller Purge Cassette Issue
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-heart-pump-controller-purge-cassette-issue-abiomed
The FDA found a possible problem with a heart-pump part made by Abiomed (owned by Johnson & Johnson), so they warned doctors about it early. When safety questions come up about medical devices, it's a sign the company needs to fix things carefully, which costs time and money.
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