Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
FDA device recall Z-0441-2024 · posted 2023-12-01 · Terminated
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Pump not detected as connected to controller due to software issue.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OZD
- Distribution
- US: AZ, CA, FL, NY & VA.
- Date initiated
- 2023-10-10
- Date posted
- 2023-12-01
- Date terminated
- 2025-03-06
- Location
- Danvers, MA
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