TERUMO CORPORATION, ASHITAKA

FDA MAUDE device safety record · 1997–2026

What the Data Shows About TERUMO CORPORATION, ASHITAKA

TERUMO CORPORATION, ASHITAKA is associated with 3,725 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1997 through 2026. Of the total, 49 are coded as death reports and 1,618 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 TERUMO CORPORATION, ASHITAKA 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 2,032 reports (54.6% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 30 years of MAUDE data, with the peak single-year volume reaching 335 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.

3,725
Total Reports
49
Death Reports
1,618
Injury Reports
20
Device Types

Event Types

Malfunction 2,032 (54.6%)
Injury 1,618 (43.4%)
Death 49 (1.3%)
21 (0.6%)
Other 5 (0.1%)

Patient Outcomes

1,989 (50.2%)
Other 1,078 (27.2%)
Required Intervention 571 (14.4%)
R 144 (3.6%)
O 87 (2.2%)
Death 48 (1.2%)
Hospitalization 19 (0.5%)
D 7 (0.2%)
H 4 (0.1%)
Congenital Anomaly 4 (0.1%)
Disability 3 (0.1%)
L 2 (0.1%)
S 2 (0.1%)
Life Threatening 2 (0.1%)

Yearly Trend

97
1997: 14
98
1998: 21
99
1999: 12
00
2000: 17
01
2001: 9
02
2002: 17
03
2003: 14
04
2004: 12
05
2005: 13
06
2006: 13
07
2007: 21
08
2008: 15
09
2009: 20
10
2010: 33
11
2011: 41
12
2012: 66
13
2013: 147
14
2014: 259
15
2015: 263
16
2016: 318
17
2017: 259
18
2018: 260
19
2019: 254
20
2020: 306
21
2021: 285
22
2022: 282
23
2023: 186
24
2024: 180
25
2025: 335
26
2026: 53

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.