PMA · Approved
Recalled · Class I · 2026Impella RP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abiomed, Inc. · PYX Temporary Non-Roller Type Right Heart Support Blood Pump
Approved on Sep 20, 2017 through premarket approval, which rests on the device’s own clinical evidence after a 174-day review. It has a Class I recall. It has been recalled 21 times, including 16 Class I recalls.
- Decided
- Sep 20, 2017
- Review
- 174 days
- Class
- Class III
- Product code
- PYX
- Recalls
- 21 (16 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P170011 has 61 supplements since 2017: 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 |
|---|---|
| 2017 | 1 |
| 2018 | 7 |
| 2019 | 10 |
| 2020 | 8 |
| 2021 | 8 |
| 2022 | 13 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 7 |
| 2026 | 2 |
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 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. |
| Jan 27, 2026 | Class I | Z-1469-2026 | Under Investigation by firm | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| Jan 27, 2026 | Class I | Z-1471-2026 | Under Investigation by firm | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| Jan 27, 2026 | Class I | Z-1470-2026 | Under Investigation by firm | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. |
| 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 |
| Dec 12, 2024 | Class I | Z-0829-2025 | Under Investigation by firm | Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement… |
| Dec 12, 2024 | Class I | Z-0830-2025 | Under Investigation by firm | Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement… |
| 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… |
| 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 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All PYX devicesPYX Temporary Non-Roller Type Right Heart Support Blood Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PYX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PYX
Too few PYX 510(k)s in any year since 2007 to give a median.
Recalls per year · PYX
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · PYX
545in 2025
MAUDE reports naming product code PYX, 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 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 7 | — | 0 | 10 |
| 2019 | 10 | — | 0 | 10 |
| 2020 | 8 | — | 0 | 10 |
| 2021 | 8 | — | 0 | 7 |
| 2022 | 13 | — | 0 | 9 |
| 2023 | 4 | — | 1 | 90 |
| 2024 | 1 | — | 2 (2) | 1,030 |
| 2025 | 7 | — | 0 | 545 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P170011 · printed Nov 6, 2026
Cite this page
510(k) Report. “P170011: Impella RP System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P170011
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026