Syringe, Balloon Inflation
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 MAUDE casebook
openFDA event book Syringe, Balloon Inflation LIGHT-BOOK · MAUDE
#361 of 1000 · 3,659 reports · 1994–2026
- BOOK 3,659 reports
- RANK #361 of 1000
- DEATH 8 death-typed
- INJ 92 injury-typed
- MALF 3,549 malfunction
- SPAN 1994–2026
- PEAK 2022: 437
- PHOTO Artificial Heart
Nearest event-volume peer: Artificial Heart (3 report gap)
Syringe, Balloon Inflation sits #361 of 1000 among tracked device types with 3,659 MAUDE reports spanning 1994–2026. 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 2.5% corpus 30.4% · below corpus mean (-27.9 pp)
- MALF 97.0% corpus 64.5% · above corpus mean (+32.5 pp)
Lead product-problem code Leak/Splash is 45% of coded problems · Lead manufacturer BOSTON SCIENTIFIC - CORK accounts for 25% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .
Syringe, Balloon Inflation in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Covid-19 Mult…
Covid-19 Multi-Analyte Antigen Device
3,713 reports
- Artificial He…
Artificial Heart
3,662 reports
- Syringe (this)
Syringe, Balloon Inflation
3,659 reports
- Transducer
Transducer, Ultrasonic, Diagnostic
3,642 reports
- Stapler, Skin
Stapler, Skin
3,639 reports
- Bone Cement
Bone Cement, Antibiotic
3,616 reports
What this shows Syringe, Balloon Inflation carries 3,659 MAUDE reports, ranked #361 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
Related Entities for Syringe, Balloon Inflation
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Syringe, Balloon Inflation, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (3,659 here).
Similar death-typed counts
Nearest other device types by death-typed report count (8 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Syringe, Balloon Inflation 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 Syringe, Balloon Inflation; 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.