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.
Device packaged in incorrect outer box carton.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Impella 5.5 with SmartAssist is a cardiac assist device designed to support patients with severe heart conditions. It is commonly used in critical care settings to help maintain blood flow during high-risk procedures or recovery periods.
The incorrect packaging could lead to confusion about the device's intended use or application, potentially risking patient safety. This is particularly problematic in high-stakes medical environments.
This recall is not part of a broader industry pattern.
The recall may cause inconvenience and concern among patients and healthcare providers relying on the Impella 5.5 for critical care, emphasizing the importance of proper device handling and packaging.
The serial numbers and catalog numbers can typically be found on the device label or packaging.
Expect a timeline of 4-6 weeks for processing any refunds or replacements once the company is contacted.
Keep records of the recall notice, communications with the company, and any receipts or documentation related to the device.
The recalled products include the Impella 5.5 with SmartAssist, Catalog Number 1000482, and Australian Configuration Code 1000770. The affected units have serial numbers 621454 and 621455. They were distributed in Australia.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
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 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.