Devices › System, balloon, intra-aortic and control
Device brand name · System balloon intra-aortic
Ac3 Optimus Iabp Na/Emea: medical device reports filed with FDA
656 reports name it, 2017–2026. Manufacturer given most often on reports: Arrow International. Product code DSP.
- 656
- device reports naming the brand
- 0% of all MAUDE reports · about 73 a year
- 5
- reports, 12 months to August 2026
- 7 in the 12 months before
- 99.4%
- classified as malfunction
- 89.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
656 medical device reports received by FDA name the brand "Ac3 Optimus Iabp Na/Emea" (system balloon intra-aortic); the manufacturer given most often on reports is Arrow International; received from July 2017 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
5 reports arrived in the 12 months to August 2026, down 29% from 7 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 malfunction (99.4%) and injury (0.6%); across all system, balloon, intra-aortic and control reports (product code DSP) death is recorded in 2.1% and malfunction in 89.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are gas/air leak (13.9%), battery problem (13%) and device alarm system (10.8%). The patient problems coded most often are no patient involvement, death and appropriate clinical signs, symptoms and conditions term/code not available. 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 68,628 reports carrying product code DSP. 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 |
|---|---|---|---|
| Gas/air leak | 91 | 13.9% | 7.7% |
| Battery problema problem with the battery | 85 | 13% | 3% |
| Device alarm system | 71 | 10.8% | 2.7% |
| Pumping stopped | 49 | 7.5% | 1.2% |
| Mechanical problema mechanical problem | 39 | 5.9% | 0.6% |
| Complete loss of power | 30 | 4.6% | 0.1% |
| Power problem | 25 | 3.8% | 0.9% |
| Incomplete or inadequate connection | 22 | 3.4% | 0.1% |
| No display/image | 22 | 3.4% | 1.8% |
| Application program freezes or fails to launch | 18 | 2.7% | 0.1% |
| Communication or transmission problemthe device could not communicate or transmit | 18 | 2.7% | 0.7% |
| Defective devicethe device was defective | 14 | 2.1% | 0.2% |
| Connection problema connection problem | 13 | 2% | 0.8% |
| Computer software problema software problem | 12 | 1.8% | 0.2% |
| Unexpected shutdown | 11 | 1.7% | 2% |
| Mechanical jam | 9 | 1.4% | 0.2% |
| Erratic or intermittent display | 8 | 1.2% | 1.2% |
| Display or visual feedback problem | 6 | 0.9% | 2.7% |
| Failure to read input signal | 6 | 0.9% | 0.7% |
| Failure to run on battery | 6 | 0.9% | 0.2% |
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 |
|---|---|---|
| No patient involvement | 10 | 1.5% |
| Deaththe patient died; cause not stated by this term | 6 | 0.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0.5% |
| Cardiac arrestthe heart stopped | 2 | 0.3% |
| Low blood pressure/ hypotension | 2 | 0.3% |
| Arrhythmia | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ac3 Optimus Iabp Na/Emea | Product code DSP | All MAUDE reports |
|---|---|---|---|
| Reports | 656 | 68,628 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 0 | 21 | 9 |
| Classified as injury | 0.6% | 7.8% | 36.2% |
| Classified as malfunction | 99.4% | 89.8% | 62.3% |
| Filed by the manufacturer | 99.7% | 96.7% | 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 DSP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cardiosave Hybrid Type B Plug | 13,759 | 2,631 | 0.4% |
| Cs300 | 4,197 | 3 | 1.9% |
| CS300 Intra-Aortic Balloon Pump, English, 110V | 2,976 | 466 | 0.3% |
| Cardiosave Hybrid W/ E/F Plug | 1,747 | 402 | 0.3% |
| Cardiosave | 1,673 | 17 | 1.7% |
| System 97 | 1,659 | 0 | 1.7% |
| Cardiosave Hybrid Type I Plug | 1,411 | 485 | 0.1% |
| Sensation Plus 8fr 50cc Iab | 1,368 | 0 | 4.8% |
| Cardiosave Hybrid Type G Plug | 1,342 | 317 | 0.4% |
| Autocat2 Wave | 1,327 | 0 | 1.4% |
| CS300 Intra-Aortic Balloon Pump, English, 220V | 1,146 | 207 | 0.2% |
| Cs100 | 1,012 | 0 | 3.7% |
| SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) | 985 | 491 | 1.4% |
| CS100 Intra-Aortic Balloon Pump, English, 220V | 950 | 159 | 0.4% |
| Stat Dl 9 5 Fr 40 Cc Iab | 907 | 0 | 3% |
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 Ac3 Optimus Iabp Na/Emea reports
How many FDA reports name Ac3 Optimus Iabp Na/Emea?
656 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.
What kinds of events are reported?
malfunction (99.4%) and injury (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
gas/air leak (13.9%), battery problem (13%), device alarm system (10.8%), pumping stopped (7.5%) and mechanical problem (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Ac3 Optimus Iabp Na/Emea 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.