2026 data FDA MAUDE openFDA

Ventricular (Assist) Bypass

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 Ventricular Bypass HEAVY-BOOK · MAUDE

#26 of 1000 · 153,365 reports · 1992–2026

  • BOOK 153,365 reports
  • RANK #26 of 1000
  • DEATH 22,316 death-typed
  • INJ 74,817 injury-typed
  • MALF 56,096 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 20,216
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (593 report gap)

Ventricular (Assist) Bypass sits #26 of 1000 among tracked device types with 153,365 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 →

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 14.6% corpus 1.5% · above corpus mean (+13.0 pp)
  • INJ 48.8% corpus 30.4% · above corpus mean (+18.3 pp)
  • MALF 36.6% corpus 64.5% · below corpus mean (-27.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 48% of coded problems · Lead manufacturer THORATEC CORPORATION accounts for 45% of manufacturer-tagged reports · Top event location I is 51% of location-tagged rows .

Ventricular Bypass in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Ventricular (Assist) Bypass carries 153,365 MAUDE reports, ranked #26 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 74,817 (48.8%)
Malfunction 56,096 (36.6%)
Death 22,316 (14.6%)
81 (0.1%)
Other 54 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

56,478 (26.7%)
Hospitalization 37,760 (17.8%)
R 34,460 (16.3%)
Death 21,532 (10.2%)
Required Intervention 19,374 (9.2%)
L 13,093 (6.2%)
Life Threatening 9,330 (4.4%)
Other 8,601 (4.1%)
H 8,376 (4.0%)
O 1,457 (0.7%)
D 993 (0.5%)
S 195 (0.1%)
Disability 40 (0.0%)
Congenital Anomaly 12 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 68,559
Pumping Problem 8,923
Battery Problem 8,355
Mechanical Problem 8,094
Infusion or Flow Problem 6,696
Power Problem 6,194
Pumping Stopped 4,354
Break 3,658
Connection Problem 3,093
Electrical Power Problem 3,011
Material Integrity Problem 2,853
Disconnection 2,697
Electrical /Electronic Property Problem 2,515
Complete Loss of Power 2,511
Insufficient Information 2,288
Obstruction of Flow 1,759
No Apparent Adverse Event 1,601
Decreased Pump Speed 1,516
Material Twisted/Bent 1,486
Device Stops Intermittently 1,483

Yearly Trend

92
1992: 1
94
1994: 1
95
1995: 6
96
1996: 64
97
1997: 100
98
1998: 73
99
1999: 77
00
2000: 96
01
2001: 112
02
2002: 97
03
2003: 215
04
2004: 213
05
2005: 208
06
2006: 266
07
2007: 224
08
2008: 264
09
2009: 529
10
2010: 687
11
2011: 1,082
12
2012: 2,120
13
2013: 2,941
14
2014: 3,903
15
2015: 6,771
16
2016: 7,190
17
2017: 9,055
18
2018: 12,660
19
2019: 20,216
20
2020: 14,239
21
2021: 15,766
22
2022: 15,994
23
2023: 13,055
24
2024: 13,046
25
2025: 10,581
26
2026: 1,513

Related Entities for Ventricular (Assist) Bypass

Event Locations

I 78,067 (50.9%)
66,064 (43.1%)
HOSPITAL 5,698 (3.7%)
HOME 2,835 (1.8%)
OTHER 293 (0.2%)
NO INFORMATION 236 (0.2%)
INVALID DATA 62 (0.0%)
NURSING HOME 41 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 22 (0.0%)
OUTPATIENT TREATMENT FACILITY 20 (0.0%)
AMBULATORY SURGICAL FACILITY 12 (0.0%)
NOT APPLICABLE 10 (0.0%)
UNKNOWN 5 (0.0%)

Compare THORATEC CORPORATION vs HEARTWARE, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Ventricular Bypass, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Ventricular Bypass 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 Ventricular Bypass; 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.