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FDA-Device2026-06-03Class IPROCESSING DEFECT

Abiomed Impella Controller recalled for hardware defects affecting motor control and device function

Abiomed
ELECTRICAL SHOCKOTHERNationwide distribution

Abiomed Impella Controller recalled for hardware defects

Abiomed identified that certain Automated Impella Controller (AIC) units have internal hardware issues that could affect device operation. These include cable and component positioning problems that may interrupt motor controls, cause startup failures, or prevent the device from booting properly. Abiomed is implementing hardware updates through its servicing process.

  • Contact Abiomed if you operate or maintain an AIC unit to determine if your serial number is affected.
  • Do not use an affected AIC unit until it has received the required hardware update through Abiomed's service.
  • Refer to the FDA notice or Abiomed for specific serial numbers requiring updates.
Hazard

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.

Sold states
Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom;
Affected count
91 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
Automated Impella Controller (AIC); Product Code: 0042-0000-US;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2211-2026

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