Devices › System, balloon, intra-aortic and control
Device brand name · Intra-aortic balloon
Datascope: medical device reports filed with FDA
356 reports name it, 1992–2014. Manufacturer given most often on reports: Datascope. Product code DSP.
- 356
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 40.2%
- classified as malfunction
- 89.8% across the product code
- 7.3%
- classified as death, as reported
- 26 reports · not verified by FDA
FDA's MAUDE database holds 356 reports that name the brand "Datascope" (intra-aortic balloon), received between July 1992 and September 2014; the manufacturer given most often on reports is Datascope. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and 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 (44.4%), malfunction (40.2%) and death (7.3%); 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 balloon rupture (19.9%), blood in tubing (12.6%) and balloon leak(s) (10.7%). The patient problems coded most often are therapy/non-surgical treatment, additional, death and surgical procedure. 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
No report naming Datascope was received in the five years to August 2026; the latest was received in September 2014.
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 |
|---|---|---|---|
| Balloon rupture | 71 | 19.9% | 1.4% |
| Blood in tubing | 45 | 12.6% | 3.1% |
| Balloon leak(s) | 38 | 10.7% | 3.4% |
| Replace | 35 | 9.8% | 5.5% |
| Device, removal of (non-implant) | 24 | 6.7% | 1.7% |
| Leak/splashthe device leaked | 22 | 6.2% | 5.5% |
| Device issuea problem with the device | 16 | 4.5% | 0.4% |
| Explanted | 15 | 4.2% | 0.1% |
| Difficult to removethe device was hard to remove | 14 | 3.9% | 1% |
| Material rupture | 14 | 3.9% | 1.3% |
| Alarm, audible | 9 | 2.5% | 1.6% |
| Other (for use when an appropriate device code cannot be identified) | 9 | 2.5% | 1.2% |
| Inflation problem | 8 | 2.2% | 3.3% |
| Difficult to insertthe device was hard to insert | 5 | 1.4% | 3.1% |
| Failure to pump | 5 | 1.4% | 0.4% |
| Air leak | 4 | 1.1% | 0.7% |
| Breakthe device broke | 4 | 1.1% | 2.9% |
| Crackthe device cracked | 4 | 1.1% | 0.3% |
| Component(s), broken | 3 | 0.8% | 0% |
| Device alarm system | 3 | 0.8% | 2.7% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, additional | 31 | 8.7% |
| Deaththe patient died; cause not stated by this term | 30 | 8.4% |
| Surgical procedure | 27 | 7.6% |
| Therapy/non-surgical treatment, aborted/stopped | 17 | 4.8% |
| Surgical procedure, additional | 16 | 4.5% |
| Bleeding | 12 | 3.4% |
| Other (for use when an appropriate patient code cannot be identified) | 8 | 2.2% |
| Blood pressure, low | 4 | 1.1% |
| Low blood pressure/ hypotension | 4 | 1.1% |
| Burn(s)a burn | 3 | 0.8% |
| Cardiac arrestthe heart stopped | 3 | 0.8% |
| Cardiac insufficiency | 3 | 0.8% |
| Cardiopulmonary arrest | 3 | 0.8% |
| Congestive heart failure | 3 | 0.8% |
| Foreign body, removal of | 3 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Datascope | Product code DSP | All MAUDE reports |
|---|---|---|---|
| Reports | 356 | 68,628 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 73 | 21 | 9 |
| Classified as injury | 44.4% | 7.8% | 36.2% |
| Classified as malfunction | 40.2% | 89.8% | 62.3% |
| Filed by the manufacturer | 4.5% | 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 Datascope reports
How many FDA reports name Datascope?
356 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (44.4%), malfunction (40.2%) and death (7.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
balloon rupture (19.9%), blood in tubing (12.6%), balloon leak(s) (10.7%), replace (9.8%) and device, removal of (non-implant) (6.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (40.4%), distributor reports (10.4%) and manufacturer reports (4.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Datascope 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.