A Recall Does Not Always Mean Stop Using It

The FDA has classified Abiomed's removal of Automated Impella Controllers as its most serious recall type after purge-system component failures were associated with 37 serious injuries and three deaths. Yet hospitals may continue using their controllers while waiting for service.

That combination can sound contradictory: a Class I recall, a phased global removal and continued clinical use. It is also an important lesson for surgical and procedural teams. A recall does not always mean every device must be taken out of service immediately. Sometimes it means teams must understand a known failure mode, maintain a backup and be ready to act without hesitation.

What is failing

The Automated Impella Controller is the control interface for the Impella catheter. It manages catheter performance, displays alarms and provides information about catheter position across the aortic valve.

Abiomed is removing controllers because the purge flag inside the purge pressure sensor assembly may fail. The purge flag helps the controller recognize that the purge disc is inserted correctly. When recognition fails, the controller may display a "Purge Disc Disconnected" or "Purge Disc not Detected" alarm.

All Automated Impella Controllers worldwide are included in the phased removal. Abiomed plans to replace the purge flag and purge retainer components through annual preventive maintenance or direct service outreach.

What clinicians are instructed to do

Hospitals may continue using existing inventory to preserve access to mechanical circulatory support while awaiting service. If the alarm appears, the instructions are to reinsert the purge disc. If that does not clear the alarm, the team should switch to a backup Automated Impella Controller.

FDA also highlights two prevention measures: clean the controller housing only with the mild detergent specified in the instructions for use, because improper cleaning may damage plastic components, and complete preventive maintenance annually.

Why timing changes the risk

A failure before support begins may delay a procedure while the team changes controllers. In a stable elective case, that delay may be manageable. In a patient with hemodynamic instability, time without mechanical circulatory support can quickly become dangerous.

A failure during active support creates a different emergency. Support may continue temporarily while purge delivery is interrupted and the team prepares to exchange the controller. The patient may require additional stabilization before the brief interruption involved in the exchange.

That is why an available backup is not enough. The backup must be functional, accessible and familiar to the people expected to use it.

Questions every Impella program should answer

• Where is the backup controller during setup, transport and active support?

• Has it been checked, maintained and confirmed ready for use?

• Can every relevant team member recognize the purge-disc alarms and state the first two actions?

• Who leads the controller exchange while others stabilize the patient?

• How will biomedical engineering and Abiomed service track each controller through the phased correction?

• Are cleaning personnel using only the method specified in the instructions for use?

The larger OR lesson

Recalls are clinical workflow events, not simply supply-chain notifications. The people receiving a recall letter may not be the people responding to the alarm at the bedside. Closing that gap requires a short, practical response plan that can survive an emergency.

For teams using Impella support, the goal is not to memorize every paragraph of the recall. It is to know the alarm, know the immediate action, know where the backup is and know who will do what when seconds matter.

U.S. Food and Drug Administration. (Updated September 24, 2026). “Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers.” Cite for the Class I classification, reported injuries and deaths, affected controllers, phased removal, and FDA’s current instructions for facilities awaiting service.