CORDIS CORPORATION

FDA MAUDE device safety record · 1992–2026

What the Data Shows About CORDIS CORPORATION

CORDIS CORPORATION is associated with 10,548 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2026. Of the total, 183 are coded as death reports and 4,911 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for CORDIS CORPORATION should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 5,395 reports (51.1% of total). Patient-outcome categorizations are reported across 15 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 1,508 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

10,548
Total Reports
183
Death Reports
4,911
Injury Reports
20
Device Types

Event Types

Malfunction 5,395 (51.1%)
Injury 4,911 (46.6%)
Death 183 (1.7%)
50 (0.5%)
Other 9 (0.1%)

Patient Outcomes

5,812 (45.1%)
Life Threatening 2,595 (20.1%)
R 1,238 (9.6%)
Hospitalization 942 (7.3%)
L 781 (6.1%)
Required Intervention 758 (5.9%)
S 225 (1.7%)
Death 195 (1.5%)
Other 152 (1.2%)
Disability 66 (0.5%)
H 55 (0.4%)
O 53 (0.4%)
D 5 (0.0%)
C 2 (0.0%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

92
1992: 3
93
1993: 2
94
1994: 2
95
1995: 1
96
1996: 14
97
1997: 61
98
1998: 297
99
1999: 42
00
2000: 7
01
2001: 11
02
2002: 2
03
2003: 33
04
2004: 33
05
2005: 42
06
2006: 136
07
2007: 148
08
2008: 345
09
2009: 262
10
2010: 161
11
2011: 146
12
2012: 134
13
2013: 171
14
2014: 400
15
2015: 852
16
2016: 732
17
2017: 337
18
2018: 429
19
2019: 455
20
2020: 1,319
21
2021: 1,508
22
2022: 999
23
2023: 205
24
2024: 319
25
2025: 929
26
2026: 11

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.