Tag: abiomed

FDA Issues Early Alert for Impella Heart Pump Introducer Kits Over Bleeding Risk

18 Jun 2026 4:34 p.m. · Source: US Food and Drug Administration

The FDA issued an Early Alert for Abiomed and Oscor's Introducer Kits used with Impella heart pumps due to potential leakage. Manufacturing issues increase access-site bleeding risk, prompting a recommendation for corrections before continued use to prevent serious complications.

Health Politics and Government Medical Science Federal Government FDA Abiomed Oscor Impella Heart Pump Medical Device Product Recall Bleeding Risk Food Recalls Drugs
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…

Health Business Science & Technology Medical Science Federal Government Legal Abiomed FDA 14Fr Low Profile Introducer Kit Thrombus Formation Medical Device Product Recall Patient Safety Food Recalls Drugs
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.

Health Business Science & Technology Politics and Government Medical Science Federal Government Legal Computers and Internet Abiomed Automated Impella Controller AIC Impella FDA Medical Device Recall Product Recall Food Recalls Drugs

Tag: abiomed

FDA Issues Early Alert for Impella Heart Pump Introducer Kits Over Bleeding Risk

FDA Warns of Blood Clot Risk with Abiomed Introducer Kits

FDA Alerts Public to Heart Pump Controller Issue from Abiomed