MEDTRONIC XOMED INC.

FDA MAUDE device safety record · 2002–2026

What the Data Shows About MEDTRONIC XOMED INC.

MEDTRONIC XOMED INC. is associated with 11,835 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2002 through 2026. Of the total, 9 are coded as death reports and 787 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 MEDTRONIC XOMED INC. 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 11,032 reports (93.2% 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 21 years of MAUDE data, with the peak single-year volume reaching 2,862 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.

11,835
Total Reports
9
Death Reports
787
Injury Reports
20
Device Types

Event Types

Malfunction 11,032 (93.2%)
Injury 787 (6.6%)
Death 9 (0.1%)
6 (0.1%)
Other 1 (0.0%)

Patient Outcomes

10,823 (92.6%)
Required Intervention 419 (3.6%)
Other 291 (2.5%)
Life Threatening 36 (0.3%)
Disability 32 (0.3%)
Hospitalization 29 (0.2%)
R 25 (0.2%)
H 10 (0.1%)
L 9 (0.1%)
Death 8 (0.1%)
O 7 (0.1%)
S 4 (0.0%)

Yearly Trend

02
2002: 1
05
2005: 2
08
2008: 8
09
2009: 3
10
2010: 22
11
2011: 46
12
2012: 1
13
2013: 4
14
2014: 290
15
2015: 376
16
2016: 395
17
2017: 470
18
2018: 714
19
2019: 711
20
2020: 661
21
2021: 688
22
2022: 840
23
2023: 1,181
24
2024: 2,286
25
2025: 2,862
26
2026: 274

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.