DATASCOPE CORP.

Manufacturer adverse-event records for DATASCOPE 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 · 1993–2026 · heavy-book · elevated Death-code · injury-light

Death-code intensity

DATASCOPE CORP. carries an elevated Death-code share

Death-coded event_type rows are 492 of 24,315 (2.02% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for DATASCOPE CORP.

The standout signal for DATASCOPE CORP. is Death-code intensity: 2.02% of 24,315 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair DATASCOPE CORP. 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 20 device types, led in this extract by Malfunction at 22,867 (94.0% of event_type total). Peak single-year volume reaches 6,349 reports across 34 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

24,315
Total Reports
492
Event-type Death
860
Injury Reports
20
Device Types

Event Types

Malfunction 22,867 (94.0%)
Injury 860 (3.5%)
Death 492 (2.0%)
54 (0.2%)
Other 42 (0.2%)

Patient Outcomes

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

22,759 (93.1%)
Death 505 (2.1%)
Required Intervention 492 (2.0%)
Other 237 (1.0%)
Life Threatening 212 (0.9%)
R 172 (0.7%)
Hospitalization 25 (0.1%)
L 14 (0.1%)
Invalid Data 9 (0.0%)
O 7 (0.0%)
H 5 (0.0%)
D 4 (0.0%)
S 3 (0.0%)
Disability 3 (0.0%)

Yearly Trend

93
1993: 5
94
1994: 56
95
1995: 54
96
1996: 612
97
1997: 2,535
98
1998: 1,943
99
1999: 585
00
2000: 306
01
2001: 297
02
2002: 83
03
2003: 71
04
2004: 43
05
2005: 50
06
2006: 74
07
2007: 46
08
2008: 45
09
2009: 62
10
2010: 71
11
2011: 67
12
2012: 88
13
2013: 144
14
2014: 1,216
15
2015: 61
16
2016: 33
17
2017: 6
18
2018: 18
19
2019: 19
20
2020: 24
21
2021: 17
22
2022: 26
23
2023: 1,209
24
2024: 5,905
25
2025: 6,349
26
2026: 2,195