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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.1650 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Syringe, Balloon Inflation LIGHT-BOOK · MAUDE
#367 of 1000 · 3,683 reports · 1994–2026
- BOOK 3,683 reports
- RANK #367 of 1000
- DEATH 8 death-typed
- INJ 92 injury-typed
- MALF 3,573 malfunction
- SPAN 1994–2026
- PEAK 2022: 437
- PHOTO Artificial Heart
Nearest event-volume peer: Artificial Heart (9 report gap)
Syringe, Balloon Inflation sits #367 of 1000 among tracked device types with 3,683 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 →
Malfunction reports run above the device-type norm
Syringe, Balloon Inflation carries 97.0% MALFUNCTION-coded reports, 32.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 2.5% corpus 30.3% · below corpus mean (-27.8 pp)
- MALF 97.0% corpus 64.8% · above corpus mean (+32.2 pp)
Lead product-problem code Leak/Splash is 36% 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
- Stapler, Skin
Stapler, Skin
3,772 reports
- Bone Cement
Bone Cement, Antibiotic
3,697 reports
- Artificial He…
Artificial Heart
3,692 reports
- Syringe (this)
Syringe, Balloon Inflation
3,683 reports
- Sensor
Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
3,653 reports
- Tissue Adhesi…
Tissue Adhesive For The Topical Approximation Of Skin
3,631 reports
What this shows Syringe, Balloon Inflation carries 3,683 MAUDE reports, ranked #367 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 fell to 66 in 2025, down from an average of 321 in the two years before.
Related Entities for Syringe, Balloon Inflation
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Syringe, Balloon Inflation: 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 (3,683 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.