Impella Heart Pump recallZ-0441-2024 · Abiomed, Inc. · initiated Oct 10, 2023
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abiomed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Pump not detected as connected to controller due to software issue.
FDA root cause category: Software design
What the company is doing
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 [email protected] 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.
Recall details
- Recall number
- Z-0441-2024
- Status
- Terminated
- Initiated by the company
- Oct 10, 2023
- Posted by the FDA
- Dec 1, 2023
- Recalling firm
- Abiomed, Inc.
- Product code
- OZD
- FDA submissions
- P140003
- Distribution
- US: AZ, CA, FL, NY & VA.
Product description
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Impella 0042-0040-USAbiomed, Inc. · Temporary Non-Roller Type Right Heart Support Blood Pump8 recalls41 deaths1,305 reports
Product lines
Other devices under the same FDA submission
11 devices cleared under P140003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Impella 0048-0045Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump5 recalls1,269 deaths11,112 reports
- Impella 1000100Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump5 recalls848 deaths6,093 reports
- Impella 1000080Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump7 recalls987 deaths5,084 reports
- Impella 0042-0000-USAbiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump12 recalls120 deaths2,456 reports
- Impella 0550-0008Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump4 recalls87 deaths1,005 reports
- Impella 0048-0024Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump2 recalls40 deaths296 reports
- Impella 0048-0032Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump3 recalls3 deaths42 reports
- Impella 0048-0003Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump6 deaths124 reports
- Impella 1000200Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump9 deaths84 reports
- Impella 0043-0003Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump1 recall7 reports
- Impella CP with SmartAssist 1000413Abiomed, Inc. · Temporary Non-Roller Type Left Heart Support Blood Pump1 recall1 death5 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93406).
- Z-0440-2024 · TerminatedAutomated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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