System, Balloon, Intra-Aortic And Control
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.3535 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book System, Balloon, Intra-Aortic And Control MID-BOOK · MAUDE
#59 of 1000 · 67,890 reports · 1992–2026
- BOOK 67,890 reports
- RANK #59 of 1000
- DEATH 1,470 death-typed
- INJ 5,310 injury-typed
- MALF 60,902 malfunction
- SPAN 1992–2026
- PEAK 2025: 7,504
- PHOTO Instrument
Nearest event-volume peer: Instrument, Ultrasonic Surgical (162 report gap)
System, Balloon, Intra-Aortic And Control sits #59 of 1000 among tracked device types with 67,890 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
System, Balloon, Intra-Aortic And Control carries 89.7% MALFUNCTION-coded reports, 24.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
- INJ 7.8% corpus 30.3% · below corpus mean (-22.5 pp)
- MALF 89.7% corpus 64.8% · above corpus mean (+24.9 pp)
Lead product-problem code Gas/Air Leak is 11% of coded problems · Lead manufacturer DATASCOPE CORP. accounts for 45% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .
System, Balloon, Intra-Aortic And Control in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Gastroscope A…
Gastroscope And Accessories, Flexible/Rigid
73,278 reports
- Set
Set, Administration, For Peritoneal Dialysis, Disposable
72,142 reports
- System
System, Endovascular Graft, Aortic Aneurysm Treatment
71,804 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
70,458 reports
- Instrument
Instrument, Ultrasonic Surgical
68,052 reports
- System (this)
System, Balloon, Intra-Aortic And Control
67,890 reports
What this shows System, Balloon, Intra-Aortic And Control carries 67,890 MAUDE reports, ranked #59 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (7,504) held close to the prior two-year average of 7,150.
Related Entities for System, Balloon, Intra-Aortic And Control
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for System, Balloon, Intra-Aortic And Control: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (67,890 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1,470 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for System, Balloon, Intra-Aortic And Control are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System, Balloon, Intra-Aortic And Control; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.