MedTech Current
Menu

Device RecallsRecall Brief

Class IOpen, Classified

FDA Classifies Abiomed Automated Impella Controller Recall as Class I

FDA classified Abiomed's Automated Impella Controller removal as Class I after purge-flag failures caused purge-cassette recognition problems that can delay support or require controller exchange during active support.

Type
Recall Brief
Published

Decision support

Decision summary

Official recall information is separated from MedTech Current editorial analysis.

Official recall information

What happened

FDA classified Abiomed's phased removal of Automated Impella Controllers as Class I on September 24, 2026. Failures of the purge flag within the purge pressure sensor assembly can prevent recognition of the purge disc and trigger “Purge Disc Disconnected” or “Purge Disc not Detected” alarms. An AIC exchange is needed to resolve the issue. FDA states that a failure before support starts may delay a procedure, while a failure during support can require a planned controller exchange and brief interruption. As of August 17, Abiomed had reported 37 serious injuries and three deaths associated with the issue.

MedTech Current analysis

Why it matters

A controller exchange during setup or active mechanical circulatory support can create a time-sensitive operational challenge. The FDA notice says hospital inventory may continue to be used while awaiting service to maintain continuity of care. Facilities should identify affected controllers, know the alarm response, and coordinate the phased service replacement.

Actions by role

MedTech Current analysis — editorial interpretation, not FDA-authored guidance.

  • MedTech Current analysisHealthcare facilitiesIdentify affected controllers and ensure clinical teams know the purge-disc reinsertion and backup-controller steps in the FDA notice.
  • MedTech Current analysisBiomedical engineering and supply teamsCoordinate with Abiomed's field service team for replacement and maintain readiness for a backup controller during affected use.
  • MedTech Current analysisManufacturers and suppliersCheck whether affected units were transferred to another facility and pass along the official notice where needed.

Official recall information

Official actions

According to FDA and Abiomed's customer instructions:

  • While awaiting service, hospital inventory may continue to be used to ensure continuity of care.
  • If a purge-flag failure causes an associated alarm, reinsert the purge disc; if the alarm does not clear, switch to a backup Automated Impella Controller.
  • Clean the AIC housing with mild detergent as specified in the Instructions for Use, and perform routine preventive maintenance annually.
  • Work with Abiomed's field service team to schedule replacement of the purge flag and purge retainer components.
  • Forward the notice to relevant personnel and any facility that received affected devices, and post a copy in a visible area.

Detailed recall information

Detailed sourced information from the published Recall Brief follows.

What changed

Abiomed is removing Automated Impella Controllers (AICs) after purge-flag failures within the purge pressure sensor assembly led to purge-cassette recognition problems. FDA classified the action as Class I on September 24, 2026. The FDA recall database lists three records under Recall Event ID 99671: Z-3148-2026, Z-3149-2026, and Z-3150-2026.

If the failure occurs during setup, the controller may display a “Purge Disc Disconnected” alarm and support may be delayed. During active support, a “Purge Disc not Detected” alarm may appear; an AIC exchange is required to resolve the issue. As of August 17, Abiomed had reported 37 serious injuries and three deaths associated with the issue.

Who and what are affected

FDA’s notice identifies three U.S. configurations: Impella Controller, Packaged, US; Impella Optical Controller, Packaged, US; and Optical, AIC, Impella Controller, Pkgd, US. The FDA records contain the specific device identifiers and serial-number scope. Abiomed states that all AIC units globally are within the phased removal. FDA lists Abiomed, Inc. as the recalling firm.

What affected organizations should do

Healthcare facilities and clinical users

According to FDA and Abiomed’s customer instructions, hospital inventory may continue to be used while awaiting service to maintain continuity of care. If an associated alarm occurs, reinsert the purge disc; if the alarm does not clear, switch to a backup AIC. Coordinate with Abiomed’s service team to replace the purge flag and purge retainer components. Follow the device Instructions for Use for cleaning and annual preventive maintenance.

Distributors and receiving facilities

Pass the notice to relevant personnel and to any facility that received affected devices. Abiomed is implementing a phased removal and will coordinate service for affected units.

MedTech Current analysis

The Class I classification reflects the potential for serious injury or death if the issue is not addressed. Facilities should treat inventory identification, alarm response, backup-controller readiness, and service coordination as linked parts of their continuity planning. Follow the FDA and manufacturer instructions for the specific controller in use.