Devices › System, balloon, intra-aortic and control
Device brand name · System balloon intra-aortic and control
Cardiosave: medical device reports filed with FDA
1,673 reports name it, 2012–2026. Manufacturer given most often on reports: Datascope Mahwah. Product code DSP.
- 1,673
- device reports naming the brand
- 0% of all MAUDE reports · about 118 a year
- 17
- reports, 12 months to August 2026
- 13 in the 12 months before
- 96.2%
- classified as malfunction
- 89.8% across the product code
- 1.7%
- classified as death, as reported
- 29 reports · not verified by FDA
1,673 medical device reports received by FDA name the brand "Cardiosave" (system balloon intra-aortic and control); the manufacturer given most often on reports is Datascope Mahwah; received from May 2012 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
17 reports arrived in the 12 months to August 2026, up 31% from 13 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 (96.2%), injury (1.9%) and death (1.7%); 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 device displays incorrect message (21.8%), device operates differently than expected (12.3%) and loss of power (6.4%). The patient problems coded most often are no patient involvement, death and cardiopulmonary arrest. 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 |
|---|---|---|---|
| Device displays incorrect message | 365 | 21.8% | 4.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 206 | 12.3% | 1.6% |
| Loss of powerthe device lost power | 107 | 6.4% | 1.1% |
| Gas/air leak | 84 | 5% | 7.7% |
| Breakthe device broke | 75 | 4.5% | 2.9% |
| No display/image | 69 | 4.1% | 1.8% |
| Battery problema problem with the battery | 61 | 3.6% | 3% |
| Failure to charge | 59 | 3.5% | 1.2% |
| Failure to power up | 58 | 3.5% | 2.2% |
| Inability to auto-fill | 58 | 3.5% | 4.3% |
| Leak/splashthe device leaked | 58 | 3.5% | 5.5% |
| Noise, audible | 55 | 3.3% | 1.1% |
| Device inoperablethe device could not be used | 49 | 2.9% | 0.3% |
| Charging problem | 41 | 2.5% | 1.1% |
| Pumping stopped | 29 | 1.7% | 1.2% |
| Display or visual feedback problem | 27 | 1.6% | 2.7% |
| Communication or transmission problemthe device could not communicate or transmit | 21 | 1.3% | 0.7% |
| Computer operating system problem | 21 | 1.3% | 0.1% |
| Device alarm system | 19 | 1.1% | 2.7% |
| Pressure problem | 19 | 1.1% | 1.6% |
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 | 517 | 30.9% |
| Deaththe patient died; cause not stated by this term | 24 | 1.4% |
| Cardiopulmonary arrest | 4 | 0.2% |
| Loss of consciousnesspassing out | 3 | 0.2% |
| Myocardial infarctionheart attack | 3 | 0.2% |
| Hemorrhage/blood loss/bleeding | 2 | 0.1% |
| Injurya physical injury | 2 | 0.1% |
| Low blood pressure/ hypotension | 2 | 0.1% |
| Tachycardiafast heart rate | 2 | 0.1% |
| Atrial fibrillationan irregular heart rhythm | 1 | 0.1% |
| Cardiac arrestthe heart stopped | 1 | 0.1% |
| Chest painchest pain | 1 | 0.1% |
| Chest tightness/pressure | 1 | 0.1% |
| Complaint, ill-defined | 1 | 0.1% |
| High blood pressure/ hypertension | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cardiosave | Product code DSP | All MAUDE reports |
|---|---|---|---|
| Reports | 1,673 | 68,628 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 17 | 21 | 9 |
| Classified as injury | 1.9% | 7.8% | 36.2% |
| Classified as malfunction | 96.2% | 89.8% | 62.3% |
| Filed by the manufacturer | 99.3% | 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% |
| 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% |
| Iab 8 Fr - 40 Cc Fos | 911 | 0 | 2.6% |
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 Cardiosave reports
How many FDA reports name Cardiosave?
1,673 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 17 in the latest 12 months.
What kinds of events are reported?
malfunction (96.2%), injury (1.9%) and death (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (21.8%), device operates differently than expected (12.3%), loss of power (6.4%), gas/air leak (5%) and break (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%) 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 Cardiosave 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.