Tag: abiomed

FDA Warns of Blood Clot Risk with Abiomed Introducer Kits

2 Jun 2026 6:13 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Abiomed's 14Fr Low Profile Introducer Kits due to a high rate of complaints regarding thrombus formation. This issue has led to three serious injuries, prompting Abiomed to recommend removal of all affected…

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FDA Alerts Public to Heart Pump Controller Issue from Abiomed

21 May 2026 8:04 p.m. · Source: US Food and Drug Administration

The FDA has issued an early alert regarding Abiomed's Automated Impella Controller, which may restart due to a software error, causing a temporary halt in heart pump support for patients. Abiomed has released updated use instructions.

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