Devices › Temporary non-roller type right heart support blood pump
Device brand name · Temporary non-roller type right heart support blood pump
Impella RP Flex: medical device reports filed with FDA
558 reports name it, 2023–2026. Manufacturer given most often on reports: Abiomed. Product code PYX.
- 558
- device reports naming the brand
- 0% of all MAUDE reports · about 192 a year
- 173
- reports, 12 months to August 2026
- 297 in the 12 months before
- 34.9%
- classified as malfunction
- 38.4% across the product code
- 19.5%
- classified as death, as reported
- 109 reports · not verified by FDA
558 medical device reports received by FDA name the brand "Impella RP Flex" (temporary non-roller type right heart support blood pump); the manufacturer given most often on reports is Abiomed; received from August 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
173 reports arrived in the 12 months to August 2026, down 42% from 297 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (45.5%), malfunction (34.9%) and death (19.5%); across all temporary non-roller type right heart support blood pump reports (product code PYX) death is recorded in 19% and malfunction in 38.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device sensing problem (25.8%), restricted flow rate (23.7%) and increase in pressure (9.1%). The patient problems coded most often are hemorrhage/blood loss/bleeding, hemolysis and thrombosis/thrombus. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,190 reports carrying product code PYX. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device sensing problem | 144 | 25.8% | 19.9% |
| Restricted flow rate | 132 | 23.7% | 16.1% |
| Increase in pressure | 51 | 9.1% | 7.3% |
| Pumping stopped | 36 | 6.5% | 5.7% |
| Patient device interaction problem | 21 | 3.8% | 6.3% |
| Positioning failure | 19 | 3.4% | 3.5% |
| Failure to advance | 16 | 2.9% | 4.4% |
| Patient-device incompatibilitythe device did not suit the patient | 16 | 2.9% | 7.5% |
| Failure to sense | 12 | 2.2% | 1.4% |
| Improper flow or infusion | 12 | 2.2% | 1.8% |
| Malposition of device | 12 | 2.2% | 2.6% |
| Deformation due to compressive stress | 8 | 1.4% | 2.3% |
| Activation, positioning or separation problem | 6 | 1.1% | 0.7% |
| Decrease in pressure | 6 | 1.1% | 0.5% |
| Defective devicethe device was defective | 4 | 0.7% | 0.8% |
| Difficult to advance | 4 | 0.7% | 0.5% |
| Failure to pump | 4 | 0.7% | 0.6% |
| Pressure problem | 4 | 0.7% | 0.2% |
| Difficult to removethe device was hard to remove | 3 | 0.5% | 0.6% |
| Insufficient flow or under infusion | 3 | 0.5% | 0.5% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 107 | 19.2% |
| Hemolysis | 91 | 16.3% |
| Thrombosis/thrombus | 88 | 15.8% |
| Renal failurekidney failure | 20 | 3.6% |
| Arrhythmia | 19 | 3.4% |
| Tachycardiafast heart rate | 16 | 2.9% |
| Hematuria | 14 | 2.5% |
| Thrombocytopenialow platelets | 13 | 2.3% |
| Cardiovascular dysfunction/insufficiency | 12 | 2.2% |
| Hemodynamic instability | 11 | 2% |
| Ischemia | 11 | 2% |
| Sepsisa severe body-wide response to infection | 11 | 2% |
| Hematomaa collection of blood under the skin or in tissue | 10 | 1.8% |
| Cardiac arrestthe heart stopped | 9 | 1.6% |
| Perforation of vessels | 8 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Impella RP Flex | Product code PYX | All MAUDE reports |
|---|---|---|---|
| Reports | 558 | 2,190 | 26,136,888 |
| Share of that pool | — | 25.5% | 0% |
| Classified as death, per 1,000 reports | 195 | 190 | 9 |
| Classified as injury | 45.5% | 42.6% | 36.2% |
| Classified as malfunction | 34.9% | 38.4% | 62.3% |
| Filed by the manufacturer | 99.8% | 99.5% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code PYX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Impella Rp | 1,135 | 94 | 14.9% |
| Impella | 8,457 | 8,251 | 15.2% |
| Automated Impella Controller | 3,792 | 455 | 5.6% |
| Impella CP | 20,624 | 2,463 | 12.9% |
| Automated Impella Controller Aic | 224 | 0 | 3.6% |
| Purge Cassette Gen 2, Sterile, Non QSK | 183 | 183 | 8.7% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Impella RP Flex reports
How many FDA reports name Impella RP Flex?
558 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 173 in the latest 12 months.
What kinds of events are reported?
injury (45.5%), malfunction (34.9%) and death (19.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device sensing problem (25.8%), restricted flow rate (23.7%), increase in pressure (9.1%), pumping stopped (6.5%) and patient device interaction problem (3.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Impella RP Flex was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.