# P140003: IMPELLA 2.5 System

- Pathway: PMA
- Applicant: Abiomed, Inc.
- Decided: Mar 23, 2015 after 370 days
- Product code: OZD (Temporary Non-Roller Type Left Heart Support Blood Pump)
- Device class: 3
- Recalls of this device: 25 (15 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 18, 2026 · Not classified · Z-0208-2027: Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recogniz
- Sep 18, 2026 · Not classified · Z-0209-2027: Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recogniz
- Sep 18, 2026 · Not classified · Z-0210-2027: Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recogniz
- Aug 12, 2026 · Class I · Z-3149-2026: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
- Aug 12, 2026 · Class I · Z-3148-2026: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
- Aug 12, 2026 · Class I · Z-3150-2026: The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
- May 18, 2026 · Class I · Z-2457-2026: Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
- May 14, 2026 · Class I · Z-2360-2026: Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
- Apr 20, 2026 · Class I · Z-2211-2026: 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 serv
- Feb 18, 2026 · Class I · Z-1589-2026: Increased risk of purge leaks with Generation 1 purge cassettes.
- Feb 16, 2026 · Class I · Z-1591-2026: Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
- Dec 4, 2025 · Class II · Z-1030-2026: Device packaged in incorrect outer box carton.
- Oct 1, 2025 · Class I · Z-0069-2026: Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
- Sep 16, 2025 · Class I · Z-0136-2026: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
- Jun 23, 2025 · Class I · Z-2164-2025: A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
- May 31, 2024 · Class I · Z-2319-2024: Nine (9) Impella CP pumps failed inspection and were inadvertently released.
- Dec 27, 2023 · Class I · Z-0980-2024: IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.
- Dec 6, 2023 · Class II · Z-0636-2024: The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness: Notifications via email feature; AIC alarm color on c
- Oct 10, 2023 · Class II · Z-0440-2024: Pump not detected as connected to controller due to software issue.
- Oct 10, 2023 · Class II · Z-0441-2024: Pump not detected as connected to controller due to software issue.
- Apr 17, 2023 · Class I · Z-1590-2023: The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
- Mar 1, 2021 · Class II · Z-1175-2024: Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC
- Sep 4, 2019 · Class II · Z-0345-2020: This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 seco
- Feb 19, 2019 · Class II · Z-3251-2026: Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal t
- Jan 17, 2011 · Class I · Z-2238-2026: Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2.

Source page: https://510kreport.com/device/P140003
Methodology: https://510kreport.com/methodology