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 13,750 of 67,533 (20.36% · elevated tercile among 443 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: 20.36% of 67,533 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 31,633 (46.8% of event_type total). Peak single-year volume reaches 8,140 reports across 26 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

67,533
Total Reports
13,750
Event-type Death
31,633
Injury Reports
16
Device Types

Event Types

Injury 31,633 (46.8%)
Malfunction 22,113 (32.7%)
Death 13,750 (20.4%)
31 (0.0%)
Other 6 (0.0%)

Patient Outcomes

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

23,983 (25.9%)
Hospitalization 16,795 (18.1%)
R 16,048 (17.3%)
Death 13,073 (14.1%)
Required Intervention 9,470 (10.2%)
H 4,784 (5.2%)
L 2,568 (2.8%)
Other 2,342 (2.5%)
Life Threatening 1,686 (1.8%)
O 1,067 (1.2%)
D 810 (0.9%)
S 76 (0.1%)
Disability 14 (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: 8,140
24
2024: 7,579
25
2025: 7,793
26
2026: 1,063