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FDA product code DSP · class 2 · Cardiovascular
System, balloon, intra-aortic and control: medical device reports filed with FDA
68,628 reports carry this product code, 1992–2026; 30 brands with a page.
- 68,628
- reports with this product code
- 0.3% of all MAUDE reports
- 9,228
- reports, 12 months to August 2026
- 7,369 in the 12 months before
- 89.8%
- classified as malfunction
- 62.3% across all reports
- 2.1%
- classified as death, as reported
- 0.9% across all reports
Product code DSP is FDA's classification for "System, balloon, intra-aortic and control" (cardiovascular panel), a class 2 device. 68,628 medical device reports carry this product code, 0.3% of the MAUDE database, from January 1992 to August 2026.
9,228 reports arrived in the 12 months to August 2026, up 25% from 7,369 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 (89.8%), injury (7.8%) and death (2.1%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Datascope | 28,742 | 41.9% |
| Datascope - Mahwah | 15,286 | 22.3% |
| Arrow International | 8,862 | 12.9% |
| Arrow Intl | 4,447 | 6.5% |
| Datascope - Fairfield | 4,011 | 5.8% |
| Datascope Mahwah | 3,666 | 5.3% |
| Datascope Fairfield | 1,632 | 2.4% |
| Teleflex | 139 | 0.2% |
| St Jude Medical | 63 | 0.1% |
| Maquet | 55 | 0.1% |
| Maquet Cardiovascular | 36 | 0.1% |
| C R Bard | 24 | 0% |
| Bard | 14 | 0% |
| Boston Scientific | 8 | 0% |
| Maquet Cardiopulmonary | 3 | 0% |
Reports by month, five years
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Gas/air leak | 5,309 | 7.7% |
| Replace | 3,801 | 5.5% |
| Leak/splashthe device leaked | 3,777 | 5.5% |
| Device displays incorrect message | 3,113 | 4.5% |
| Inability to auto-fill | 2,938 | 4.3% |
| Balloon leak(s) | 2,301 | 3.4% |
| Inflation problem | 2,269 | 3.3% |
| Difficult to insertthe device was hard to insert | 2,144 | 3.1% |
| Blood in tubing | 2,137 | 3.1% |
| Battery problema problem with the battery | 2,032 | 3% |
| Breakthe device broke | 2,010 | 2.9% |
| Display or visual feedback problem | 1,867 | 2.7% |
| Device alarm system | 1,860 | 2.7% |
| Fluid/blood leak | 1,663 | 2.4% |
| Failure to power up | 1,529 | 2.2% |
| Optical problem | 1,426 | 2.1% |
| Unexpected shutdown | 1,369 | 2% |
| Failure to sense | 1,260 | 1.8% |
| No display/image | 1,254 | 1.8% |
| Device, removal of (non-implant) | 1,197 | 1.7% |
Questions about system, balloon, intra-aortic and control reports
What is product code DSP?
FDA's classification code for "System, balloon, intra-aortic and control", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.
How many reports carry this code?
68,628 reports through August 2026, 9,228 of them in the latest 12 months.
Which brands appear most often?
Cardiosave Hybrid Type B Plug (13,757), Cs300 (4,197), CS300 Intra-Aortic Balloon Pump, English, 110V (2,976), Cardiosave Hybrid W/ E/F Plug (1,747) and Cardiosave (1,673). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.