FDA Medical Device Recalls (openFDA)
Abiomed, Inc.: Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
- Recall number
- Z-0441-2024
- Recalling firm
- Abiomed, Inc.
- Product
- Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
- Status
- Terminated
- Initiated
- 2023-10-10
- Posted
- 2023-12-01
- Terminated
- 2025-03-06
- Reason
- Pump not detected as connected to controller due to software issue.
- Root cause
- Software design
- Action
- An Urgent Medical Device Correction was issued vail mail October 24. 2023. Customers are advised to examine inventory for product running AIC software version: V8.4 or V8.4.1. Do not to use the product unless software is updated. Contact adminsfs@abiomed.com to schedule the software update and return the business reply form. Forward this information to relevant personnel and any facility product may have been transferred to.
- Quantity
- not on file
- Distribution
- US: AZ, CA, FL, NY & VA.
- Lot, serial or model codes
- UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617.
- 510(k) numbers
- not on file
- PMA numbers
- ["P140003"]
- Product code
- OZD
- Firm FEI
- 1220648
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28