Devices › Temporary non-roller type left heart support blood pump
Device brand name · Temporary non-roller type left heart support blood pump
Impella 5.5 with SmartAssist S2 Set, US: medical device reports filed with FDA
578 reports name it, 2026–2026. Manufacturer given most often on reports: Abiomed - 1220648. Product code OZD.
- 578
- device reports naming the brand
- 0% of all MAUDE reports · about 578 a year
- 578
- reports, 12 months to August 2026
- 0 in the 12 months before
- 18.9%
- classified as malfunction
- 38% across the product code
- 19.6%
- classified as death, as reported
- 113 reports · not verified by FDA
FDA's MAUDE database holds 578 reports that name the brand "Impella 5.5 with SmartAssist S2 Set, US" (temporary non-roller type left heart support blood pump), received between January 2026 and August 2026; the manufacturer given most often on reports is Abiomed - 1220648. Spellings of one product vary from report to report.
578 reports arrived in the 12 months to August 2026, with none 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 (61.6%), death (19.6%) and malfunction (18.9%); across all temporary non-roller type left heart support blood pump reports (product code OZD) death is recorded in 12.8% and malfunction in 38%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device sensing problem (17%), increase in pressure (11.9%) and patient device interaction problem (11.2%). The patient problems coded most often are hemorrhage/blood loss/bleeding, hemodynamic instability and tachycardia. 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.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 45,326 reports carrying product code OZD. 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 | 98 | 17% | 7% |
| Increase in pressure | 69 | 11.9% | 3.4% |
| Patient device interaction problem | 65 | 11.2% | 6.3% |
| Malposition of device | 64 | 11.1% | 3.8% |
| Failure to advance | 42 | 7.3% | 3.7% |
| Restricted flow rate | 33 | 5.7% | 6.9% |
| False alarm | 22 | 3.8% | 0.7% |
| Material split, cut or torn | 17 | 2.9% | 0.8% |
| Fluid/blood leak | 12 | 2.1% | 2.4% |
| Deformation due to compressive stress | 9 | 1.6% | 2.2% |
| Pumping stopped | 8 | 1.4% | 4% |
| Decrease in pressure | 7 | 1.2% | 0.7% |
| Difficult or delayed positioning | 7 | 1.2% | 0.4% |
| Inaccurate flow rate | 6 | 1% | 0.4% |
| Failure to read input signal | 4 | 0.7% | 1.9% |
| Backflow | 3 | 0.5% | 0.1% |
| Crackthe device cracked | 3 | 0.5% | 0.5% |
| Device damaged by another device | 3 | 0.5% | 0.1% |
| Difficult to advance | 3 | 0.5% | 0.8% |
| Difficult to open or close | 3 | 0.5% | 0.1% |
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 | 128 | 22.1% |
| Hemodynamic instability | 70 | 12.1% |
| Tachycardiafast heart rate | 58 | 10% |
| Hemolysis | 47 | 8.1% |
| Stroke/cva | 47 | 8.1% |
| Hematomaa collection of blood under the skin or in tissue | 46 | 8% |
| Thrombosis/thrombus | 41 | 7.1% |
| Arrhythmia | 36 | 6.2% |
| Renal failurekidney failure | 31 | 5.4% |
| Thrombocytopenialow platelets | 25 | 4.3% |
| Hematuria | 21 | 3.6% |
| Low blood pressure/ hypotension | 21 | 3.6% |
| Anemialow red blood cells | 18 | 3.1% |
| Cardiac arrestthe heart stopped | 17 | 2.9% |
| Fever | 14 | 2.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Impella 5.5 with SmartAssist S2 Set, US | Product code OZD | All MAUDE reports |
|---|---|---|---|
| Reports | 578 | 45,326 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 196 | 128 | 9 |
| Classified as injury | 61.6% | 49.2% | 36.2% |
| Classified as malfunction | 18.9% | 38% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 OZD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Impella CP | 20,624 | 2,463 | 12.9% |
| Impella | 8,457 | 8,251 | 15.2% |
| Impella 5.5 | 7,582 | 1,640 | 12.5% |
| Automated Impella Controller | 3,792 | 455 | 5.6% |
| Pump 381 Pump Set (US) | 795 | 795 | 26.2% |
| Impella 5 0 | 628 | 3 | 22.3% |
| Impella 2 5 | 327 | 0 | 11.9% |
| Impella Cp Optical | 248 | 0 | 8.1% |
| Automated Impella Controller Aic | 224 | 0 | 3.6% |
| Pump 371 14f Lt Cmr Set | 210 | 210 | 23.3% |
| Impella Cp Pump | 181 | 0 | 5% |
| Impella Cp Pump Set | 167 | 0 | 3.6% |
| Purge Cassette Gen 2, Sterile, Non QSK | 183 | 183 | 8.7% |
| Kit, 14Fr Introducer, 13cm&25cm, Sterile | 401 | 396 | 8.7% |
| Impella RP Flex | 558 | 173 | 19.5% |
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 5.5 with SmartAssist S2 Set, US reports
How many FDA reports name Impella 5.5 with SmartAssist S2 Set, US?
578 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 578 in the latest 12 months.
What kinds of events are reported?
injury (61.6%), death (19.6%) and malfunction (18.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device sensing problem (17%), increase in pressure (11.9%), patient device interaction problem (11.2%), malposition of device (11.1%) and failure to advance (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Impella 5.5 with SmartAssist S2 Set, US 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.