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2026 data FDA MAUDE openFDA FDA Class III

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.

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FDA MAUDE casebook

openFDA event book Ventricular Bypass HEAVY-BOOK · MAUDE

#27 of 1000 · 157,431 reports · 1992–2026

  • BOOK 157,431 reports
  • RANK #27 of 1000
  • DEATH 23,004 death-typed
  • INJ 76,224 injury-typed
  • MALF 58,066 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 20,216
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (40 report gap)

Ventricular (Assist) Bypass sits #27 of 1000 among tracked device types with 157,431 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 sit below the device-type norm

Ventricular Bypass carries 36.9% MALFUNCTION-coded reports, 27.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 14.6% corpus 1.5% · above corpus mean (+13.1 pp)
  • INJ 48.4% corpus 30.3% · above corpus mean (+18.1 pp)
  • MALF 36.9% corpus 64.8% · below corpus mean (-27.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 46% of coded problems · Lead manufacturer THORATEC CORPORATION accounts for 46% of manufacturer-tagged reports · Top event location I is 50% 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 157,431 MAUDE reports, ranked #27 of 1000.

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

Event Types

Injury 76,224 (48.4%)
Malfunction 58,066 (36.9%)
Death 23,004 (14.6%)
81 (0.1%)
Other 55 (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.

58,205 (26.9%)
Hospitalization 38,112 (17.6%)
R 34,780 (16.1%)
Death 22,087 (10.2%)
Required Intervention 19,869 (9.2%)
L 13,295 (6.2%)
Life Threatening 9,515 (4.4%)
Other 8,742 (4.0%)
H 8,646 (4.0%)
O 1,494 (0.7%)
D 1,016 (0.5%)
S 197 (0.1%)
Disability 42 (0.0%)
Congenital Anomaly 12 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 73,767
Battery Problem 10,293
Pumping Problem 9,556
Mechanical Problem 8,679
Infusion or Flow Problem 7,643
Power Problem 7,037
Other (for use when an appropriate device code cannot be identified) 5,064
Pumping Stopped 5,039
Break 4,134
Connection Problem 3,909
Electrical Power Problem 3,266
Disconnection 3,160
Material Integrity Problem 2,953
Electrical /Electronic Property Problem 2,882
Insufficient Device Problem Information 2,869
Complete Loss of Power 2,706
Device Stops Intermittently 2,321
Obstruction of Flow 2,079
Decreased Pump Speed 1,856
No Apparent Adverse Event 1,741

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: 528
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: 5,580

Reports in 2025 (10,581) held close to the prior two-year average of 13,051.

Related Entities for Ventricular (Assist) Bypass

Top Manufacturers

THORATEC CORPORATION 70,224
HEARTWARE, INC. 63,382
HEARTWARE, INC 12,496
THORATEC CORP. 6,212
THORATEC CORP 447
HEARTWARE INC. 335
ABIOMED, INC. 234

Event Locations

I 78,045 (49.6%)
70,134 (44.5%)
HOSPITAL 5,706 (3.6%)
HOME 2,845 (1.8%)
OTHER 293 (0.2%)
NO INFORMATION 236 (0.1%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ventricular Bypass: 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 (157,431 here).

Prosthesis 157,471 Implantable Pulse Generator, Pacemaker 156,369 System, Peritoneal, Automatic Delivery 164,500 Integrated Continuous Glucose Monitoring Sy… 165,468

Similar death-typed counts

Nearest other device types by death-typed report count (23,004 here), distinct from the volume row.

Dialysate Concentrate For Hemodialysis 23,081 Coronary Drug-Eluting Stent 11,230 Implantable Cardioverter Defibrillator 10,094 Permanent Pacemaker Electrode 9,381

Read our methodology - how this data is sourced, computed, and verified.

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.