THORATEC CORPORATION

Manufacturer adverse-event records for THORATEC CORPORATION come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2001–2026 · heavy-book · elevated Death-code · balanced

Death-code intensity

THORATEC CORPORATION carries an elevated Death-code share

Death-coded event_type rows are 14,279 of 70,427 (20.27% · elevated tercile among 434 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for THORATEC CORPORATION

The standout signal for THORATEC CORPORATION is Death-code intensity: 20.27% of 70,427 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair THORATEC CORPORATION with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 16 device types, led in this extract by Injury at 32,438 (46.1% of event_type total). Peak single-year volume reaches 8,139 reports across 26 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

70,427
Total Reports
14,279
Event-type Death
32,438
Injury Reports
16
Device Types

Event Types

Injury 32,438 (46.1%)
Malfunction 23,673 (33.6%)
Death 14,279 (20.3%)
31 (0.0%)
Other 6 (0.0%)

Patient Outcomes

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

25,387 (26.5%)
Hospitalization 16,935 (17.7%)
R 16,254 (17.0%)
Death 13,531 (14.1%)
Required Intervention 9,850 (10.3%)
H 4,928 (5.1%)
L 2,705 (2.8%)
Other 2,442 (2.5%)
Life Threatening 1,815 (1.9%)
O 1,097 (1.1%)
D 832 (0.9%)
S 78 (0.1%)
Disability 15 (0.0%)
Congenital Anomaly 4 (0.0%)

Yearly Trend

01
2001: 18
02
2002: 21
03
2003: 22
04
2004: 22
05
2005: 44
06
2006: 28
07
2007: 46
08
2008: 32
09
2009: 283
10
2010: 398
11
2011: 580
12
2012: 991
13
2013: 786
14
2014: 436
15
2015: 2,553
16
2016: 2,575
17
2017: 3,412
18
2018: 5,104
19
2019: 5,359
20
2020: 6,005
21
2021: 6,952
22
2022: 7,291
23
2023: 8,139
24
2024: 7,579
25
2025: 7,793
26
2026: 3,958