9 recalls found for Abiomed. Check if any of your products are affected.
Abiomed has issued a Class I recall for 33,107 Purge Cassette units used with Impella pump sets worldwide due to purge leaks in Generation 1 cassettes. The leaks raise the risk of compromised device performance. Patients and healthcare providers should stop using the affected devices immediately and follow Abiomed's recall instructions.
Abiomed recalled 62 Automated Impella Controller units sold to hospitals internationally. The recall warns of a delayed Purge System Blocked alarm display when used with first generation Impella 5.5 pumps. Hospitals should stop using the device immediately and contact Abiomed for instructions.
Abiomed recalled 291 Impella RP with SmartAssist devices sold worldwide, including the US. A differential pressure sensor may malfunction and cause readings to drift. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Abiomed recalled 4,496 Impella RP Flex with SmartAssist devices. The recall cites a differential pressure sensor that may malfunction and drift readings. Stop using the device immediately and follow the manufacturer's recall instructions.
Abiomed recalled 179 Impella RP devices worldwide after a differential pressure sensor may drift. The fault can cause sensor values to drift, potentially affecting patient care. Stop using the device immediately and follow the recall instructions, including contacting Abiomed or your healthcare provider.
Abiomed recalled two units of the Impella 5.5 with SmartAssist on December 4, 2025. The devices were packaged in incorrect outer cartons, posing a potential hazard. Patients and healthcare providers must stop using the devices immediately.
Abiomed recalled 10,153 Automated Impella Controllers and related components due to potential cybersecurity vulnerabilities in the operating system. The recall spans multiple international product codes and was first issued for devices distributed nationwide and internationally. Providers should stop using the affected controllers and follow manufacturer instructions immediately.
Abiomed recalled 9,177 distributed Automated Impella Controllers worldwide over purge pressure concerns linked to purge retainer failures. The recall covers multiple product codes, including AIC w/Impella Connect for ECP (1000432) and various packaged controllers. Hospitals and clinicians should stop using the device and follow the manufacturer's recall instructions immediately.
Abiomed’s automated Impella Controller recall covers 71 units distributed across the US and international markets. The devices may have a Pump Driver Circuit Assembly that does not meet current specifications. This can reduce pump performance or trigger a pump stop with alarms. Clinicians and patients should follow manufacturer instructions and contact Abiomed or healthcare providers for guidance.