PMA · Approved
Recalled · Class I · 2026IMPELLA 2.5 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Approved on Mar 23, 2015 through premarket approval, which rests on the device’s own clinical evidence after a 370-day review. It has a Class I recall. It has been recalled 25 times, including 15 Class I recalls.
- Decided
- Mar 23, 2015
- Review
- 370 days
- Class
- Class III
- Product code
- OZD
- Recalls
- 25 (15 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P140003 has 127 supplements since 2015: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2015 | 4 |
| 2016 | 8 |
| 2017 | 12 |
| 2018 | 17 |
| 2019 | 19 |
| 2020 | 12 |
| 2021 | 13 |
| 2022 | 15 |
| 2023 | 8 |
| 2024 | 5 |
| 2025 | 11 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2026 | Not classified | Z-0208-2027 | Under Investigation by firm | 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 recognize the purge cassette during case setup… |
| Sep 18, 2026 | Not classified | Z-0209-2027 | Under Investigation by firm | 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 recognize the purge cassette during case setup… |
| Sep 18, 2026 | Not classified | Z-0210-2027 | Under Investigation by firm | 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 recognize the purge cassette during case setup… |
| Aug 12, 2026 | Class I | Z-3149-2026 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 servicing process; therefore, AICs that… |
| Feb 18, 2026 | Class I | Z-1589-2026 | Device Design | Increased risk of purge leaks with Generation 1 purge cassettes. |
| Feb 16, 2026 | Class I | Z-1591-2026 | Software design | 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 | Under Investigation by firm | Device packaged in incorrect outer box carton. |
| Oct 1, 2025 | Class I | Z-0069-2026 | Software design | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). |
| Sep 16, 2025 | Class I | Z-0136-2026 | Device Design | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. |
| Jun 23, 2025 | Class I | Z-2164-2025 | Device Design | 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 | Release of Material/Component prior to receiving test results | Nine (9) Impella CP pumps failed inspection and were inadvertently released. |
| Dec 27, 2023 | Class I | Z-0980-2024 | Labeling Change Control | 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 | No Marketing Application | 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 case tile feature; Sort case tiles by… |
| Oct 10, 2023 | Class II | Z-0440-2024 | Software design | Pump not detected as connected to controller due to software issue. |
| Oct 10, 2023 | Class II | Z-0441-2024 | Software design | Pump not detected as connected to controller due to software issue. |
| Apr 17, 2023 | Class I | Z-1590-2023 | Device Design | The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. |
| Mar 1, 2021 | Class II | Z-1175-2024 | Software design | 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 | Under Investigation by firm | 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 second ramp up period. The pump may have… |
| Feb 19, 2019 | Class II | Z-3251-2026 | Under Investigation by firm | 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 the AIC system performance depends on.… |
| Jan 17, 2011 | Class I | Z-2238-2026 | Under Investigation by firm | 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. There is improper alignment between… |
The 5 latest of 25 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OZD devicesOZD Temporary Non-Roller Type Left Heart Support Blood Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OZD
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZD
Too few OZD 510(k)s in any year since 2007 to give a median.
Recalls per year · OZD
9so far in 2026, the most since 2007
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · OZD
9,726in 2025
MAUDE reports naming product code OZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 (1) | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 5 | — | 0 | 0 |
| 2016 | 8 | — | 0 | 18 |
| 2017 | 12 | — | 0 | 109 |
| 2018 | 17 | — | 0 | 149 |
| 2019 | 19 | — | 2 | 300 |
| 2020 | 12 | — | 0 | 341 |
| 2021 | 13 | — | 0 | 567 |
| 2022 | 15 | — | 0 | 542 |
| 2023 | 8 | — | 3 (1) | 3,849 |
| 2024 | 5 | — | 0 | 18,590 |
| 2025 | 11 | — | 3 (2) | 9,726 |
| 2026 | 3 | — | 9 (6) | — |
https://510kreport.com/device/P140003 · printed Nov 6, 2026
Cite this page
510(k) Report. “P140003: IMPELLA 2.5 System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P140003
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026