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

Volume signature

GIVEN IMAGING LTD. is a thinner MAUDE footprint

GIVEN IMAGING LTD. accounts for 4,963 FDA MAUDE reports (#375 of 434, thin-book tercile). Death-coded event_type share is 0.10% (typical); Injury share 1.2% (injury-light).

What the volume reading shows for GIVEN IMAGING LTD.

The standout signal for GIVEN IMAGING LTD. is filing volume: 4,963 adverse-event reports in FDA MAUDE (#375 of 434, thin-book). Death-coded event_type share sits at 0.10% (typical).

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 4,891 (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.

4,963
Total Reports
5
Event-type Death
61
Injury Reports
7
Device Types

Event Types

Malfunction 4,891 (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%)
240 (4.8%)
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: 7