Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Reported: December 13, 2023 Initiated: October 10, 2023 #Z-0441-2024
Product Description
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Reason for Recall
Pump not detected as connected to controller due to software issue.
Details
- Recalling Firm
- Abiomed, Inc.
- Distribution
- US: AZ, CA, FL, NY & VA.
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.. Recalled by Abiomed, Inc..
Why was this product recalled? ▼
Pump not detected as connected to controller due to software issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0441-2024.
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