THORATEC CORP.

Manufacturer adverse-event records for THORATEC CORP. 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 · 1997–2026 · thin-book · elevated Death-code · injury-heavy

Death-code intensity

THORATEC CORP. carries an elevated Death-code share

Death-coded event_type rows are 1,059 of 6,289 (16.84% · elevated tercile among 443 manufacturers). Absolute volume is thin-book.

What the Death-code reading shows for THORATEC CORP.

The standout signal for THORATEC CORP. is Death-code intensity: 16.84% of 6,289 reports (elevated tercile), while absolute volume is thin-book.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 10 device types, led in this extract by Injury at 3,767 (59.9% of event_type total). Peak single-year volume reaches 1,949 reports across 27 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

6,289
Total Reports
1,059
Event-type Death
3,767
Injury Reports
10
Device Types

Event Types

Injury 3,767 (59.9%)
Malfunction 1,447 (23.0%)
Death 1,059 (16.8%)
Other 8 (0.1%)
7 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

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

Required Intervention 4,111 (64.0%)
Death 1,073 (16.7%)
Other 621 (9.7%)
324 (5.0%)
R 94 (1.5%)
Hospitalization 91 (1.4%)
Life Threatening 67 (1.0%)
D 12 (0.2%)
L 9 (0.1%)
O 9 (0.1%)
H 3 (0.0%)
S 3 (0.0%)
Disability 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

97
1997: 1
01
2001: 27
02
2002: 59
03
2003: 151
04
2004: 155
05
2005: 140
06
2006: 189
07
2007: 126
08
2008: 154
09
2009: 186
10
2010: 240
11
2011: 433
12
2012: 945
13
2013: 1,464
14
2014: 1,949
15
2015: 6
16
2016: 15
17
2017: 14
18
2018: 14
19
2019: 1
20
2020: 3
21
2021: 2
22
2022: 3
23
2023: 5
24
2024: 5
25
2025: 1
26
2026: 1