Instruments, Surgical, Cardiovascular
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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §870.4500 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Instruments, Surgical, Cardiovascular LIGHT-BOOK · MAUDE
#714 of 1000 · 845 reports · 1996–2026
- BOOK 845 reports
- RANK #714 of 1000
- DEATH 11 death-typed
- INJ 172 injury-typed
- MALF 637 malfunction
- SPAN 1996–2026
- PEAK 2018: 60
- PHOTO Device
Nearest event-volume peer: Device, Endoscopic Suturing (2 report gap)
Instruments, Surgical, Cardiovascular sits #714 of 1000 among tracked device types with 845 MAUDE reports spanning 1996–2026. 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
Instruments, Surgical, Cardiovascular carries 75.4% MALFUNCTION-coded reports, 10.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
- INJ 20.4% corpus 30.3% · below corpus mean (-9.9 pp)
- MALF 75.4% corpus 64.8% · above corpus mean (+10.6 pp)
Lead product-problem code Break is 21% of coded problems · Lead manufacturer TELEFLEX MEDICAL accounts for 64% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .
Instruments, Surgical, Cardiovascular in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Tubing
Tubing, Fluid Delivery
850 reports
- Posterior Met…
Posterior Metal/Polymer Spinal System, Fusion
848 reports
- Dislodger
Dislodger, Stone, Biliary
847 reports
- Incubator
Incubator, Neonatal
847 reports
- Instruments (this)
Instruments, Surgical, Cardiovascular
845 reports
- Device
Device, Endoscopic Suturing
843 reports
What this shows Instruments, Surgical, Cardiovascular carries 845 MAUDE reports, ranked #714 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 12 in 2025, down from an average of 33 in the two years before.
Related Entities for Instruments, Surgical, Cardiovascular
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Instruments, Surgical, Cardiovascular: 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 (845 here).
Similar death-typed counts
Nearest other device types by death-typed report count (11 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Instruments, Surgical, Cardiovascular 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 Instruments, Surgical, Cardiovascular; 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.