AESCULAP AG

FDA MAUDE device safety record · 1993–2026

What the Data Shows About AESCULAP AG

AESCULAP AG is associated with 5,604 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1993 through 2026. Of the total, 14 are coded as death reports and 3,749 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 AESCULAP AG 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 Injury at 3,749 reports (66.9% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 1,331 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.

5,604
Total Reports
14
Death Reports
3,749
Injury Reports
20
Device Types

Event Types

Injury 3,749 (66.9%)
Malfunction 1,838 (32.8%)
Death 14 (0.2%)
2 (0.0%)
Other 1 (0.0%)

Patient Outcomes

Required Intervention 3,246 (57.2%)
1,684 (29.7%)
Other 424 (7.5%)
Disability 117 (2.1%)
R 87 (1.5%)
O 35 (0.6%)
Hospitalization 35 (0.6%)
Death 18 (0.3%)
Life Threatening 16 (0.3%)
L 4 (0.1%)
Congenital Anomaly 3 (0.1%)
H 2 (0.0%)
S 2 (0.0%)

Yearly Trend

93
1993: 2
94
1994: 8
96
1996: 1
97
1997: 4
13
2013: 1
15
2015: 41
16
2016: 8
17
2017: 6
18
2018: 231
19
2019: 940
20
2020: 1,331
21
2021: 1,173
22
2022: 457
23
2023: 379
24
2024: 522
25
2025: 461
26
2026: 39

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.