PharmacovigilanceOfficial

FDA classes Abiomed Automated Impella Controller removal as Class I recall

🇺🇸 FDA MedWatch · Mon 09 Nov 2026

The US regulator has upgraded the Abiomed action to its most serious category, citing quality issues in heart pump controllers that could delay therapy or cause loss of haemodynamic support.

The US Food and Drug Administration has classified Abiomed's removal of certain Automated Impella Controllers (AIC) as a Class I recall, according to an update published on 9 November 2026. The classification was added on 6 November and follows an Early Alert issued on 23 September. The agency says the products and recommended actions are unchanged. It warns that continued use of the affected devices may cause serious injury or death.

The recall covers three packaged controller configurations: the Impella Controller (product number 0042-0000-US), the Impella Optical Controller (0042-0010-US) and a further optical AIC variant (0042-0040-US). Only specific consoles are affected, identified by serial number. The serial number is printed on a label on the right side of the device, and a list of impacted serial numbers is provided.

Abiomed said a retrospective review of servicing records showed that some controllers need hardware, firmware and/or software updates to address quality issues with potential safety implications. The problems include a possible failure to recognise the purge cassette during setup or change, and a sticking, unreliable button that could hinder menu selection and confirmation and may cause loss of control of the console. They also include an instability that could lead to start-up failure, and other software defects. Without the updates, patients could face delayed therapy, inadequate or lost haemodynamic support, or other serious problems. The updates exist but have not been applied consistently across all potentially affected units.

Abiomed wrote to affected customers on 18 September 2026. Hospitals may keep using their inventory while awaiting service, to maintain continuity of care. Abiomed's service team will contact customers to arrange removal, updating and return of the devices. Facilities should pass the notice to relevant staff and to any site to which affected units have been sent. As of 8 September 2026, Abiomed had reported no serious injuries or deaths linked to the issue.

The AIC is the main user interface for Impella catheters, controlling the catheter and monitoring it for alarms. Customers in the US with adverse reactions, quality problems or questions, or whose serial number is missing or illegible, should contact the Abiomed Field Service Team on 1-800-422-8666 (option 3) or at ra-abm-fieldaction@its.jnj.com. Problems can also be reported to MedWatch. By way of context, Class I is the FDA's most serious recall category, reserved for situations where a device may cause serious harm or death.

What it means for your team

  • Check device inventories against the listed product numbers, UDI-DIs and impacted serial numbers; contact Abiomed if a serial label is missing or illegible.
  • Units can stay in use pending service, so confirm Abiomed has scheduled removal, updates and return, and record the actions taken.
  • Review complaint and adverse event files for purge cassette recognition faults, unresponsive buttons, start-up failures or loss of console control, and report events via MedWatch.
  • Pass the notice to any facility that received affected units and to staff who manage, store, transport or use the controllers.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

More Pharmacovigilance All →