CORDIS CASHEL

FDA MAUDE device safety record · 2016–2025

What the Data Shows About CORDIS CASHEL

CORDIS CASHEL is associated with 4,717 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2016 through 2025. Of the total, 87 are coded as death reports and 3,496 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 CASHEL should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Injury at 3,496 reports (74.1% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 10 years of MAUDE data, with the peak single-year volume reaching 1,678 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.

4,717
Total Reports
87
Death Reports
3,496
Injury Reports
20
Device Types

Event Types

Injury 3,496 (74.1%)
Malfunction 1,134 (24.0%)
Death 87 (1.8%)

Patient Outcomes

Life Threatening 2,502 (37.1%)
1,457 (21.6%)
R 720 (10.7%)
S 624 (9.3%)
L 492 (7.3%)
Hospitalization 478 (7.1%)
O 161 (2.4%)
Other 99 (1.5%)
Death 94 (1.4%)
Required Intervention 64 (1.0%)
Disability 23 (0.3%)
H 22 (0.3%)

Yearly Trend

16
2016: 19
17
2017: 1,014
18
2018: 1,624
19
2019: 1,678
20
2020: 312
21
2021: 5
22
2022: 16
23
2023: 25
24
2024: 22
25
2025: 2

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.