GIVEN IMAGING LTD.

Manufacturer adverse-event records for GIVEN IMAGING LTD. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2003–2026 · thin-book · typical Death-code · injury-light

Injury-mix signature

GIVEN IMAGING LTD. is lighter on Injury codes

Injury-coded event_type share is 1.2% (injury-light tercile) beside 0.10% Death-coded (typical). Volume band: thin.

What the Injury-mix reading shows for GIVEN IMAGING LTD.

The standout signal for GIVEN IMAGING LTD. is Injury-mix: 1.2% Injury-coded (injury-light) beside 0.10% Death-coded, on a thin-book footprint.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 7 device types, led in this extract by Malfunction at 4,887 (98.5% of event_type total). Peak single-year volume reaches 1,617 reports across 19 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,959
Total Reports
5
Event-type Death
61
Injury Reports
7
Device Types

Event Types

Malfunction 4,887 (98.5%)
Injury 61 (1.2%)
Death 5 (0.1%)
3 (0.1%)
Other 3 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 4,684 (93.9%)
236 (4.7%)
R 24 (0.5%)
Hospitalization 24 (0.5%)
Other 8 (0.2%)
Death 5 (0.1%)
L 2 (0.0%)
O 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

03
2003: 1
08
2008: 4
09
2009: 230
10
2010: 835
11
2011: 1,435
12
2012: 1,617
13
2013: 308
14
2014: 265
15
2015: 237
16
2016: 1
17
2017: 2
19
2019: 2
20
2020: 2
21
2021: 3
22
2022: 1
23
2023: 1
24
2024: 4
25
2025: 8
26
2026: 3