COVIDIEN LP LLC NORTH HAVEN

FDA MAUDE device safety record · 2017–2026

What the Data Shows About COVIDIEN LP LLC NORTH HAVEN

COVIDIEN LP LLC NORTH HAVEN is associated with 47,494 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2017 through 2026. Of the total, 185 are coded as death reports and 7,046 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 COVIDIEN LP LLC NORTH HAVEN 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 Malfunction at 40,263 reports (84.8% 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 10 years of MAUDE data, with the peak single-year volume reaching 7,218 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.

47,494
Total Reports
185
Death Reports
7,046
Injury Reports
20
Device Types

Event Types

Malfunction 40,263 (84.8%)
Injury 7,046 (14.8%)
Death 185 (0.4%)

Patient Outcomes

39,947 (79.4%)
Required Intervention 4,632 (9.2%)
R 1,659 (3.3%)
Other 1,461 (2.9%)
Hospitalization 1,070 (2.1%)
O 460 (0.9%)
H 387 (0.8%)
S 238 (0.5%)
Death 142 (0.3%)
Disability 99 (0.2%)
Life Threatening 95 (0.2%)
L 93 (0.2%)
D 43 (0.1%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

17
2017: 4,246
18
2018: 6,293
19
2019: 7,218
20
2020: 5,357
21
2021: 5,417
22
2022: 5,106
23
2023: 5,431
24
2024: 5,883
25
2025: 2,542
26
2026: 1

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.