ARROW INTL., INC.

Manufacturer adverse-event records for ARROW INTL., INC. 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 · 1993–2015 · mid-book · elevated Death-code · balanced

Death-code intensity

ARROW INTL., INC. carries an elevated Death-code share

Death-coded event_type rows are 195 of 8,068 (2.42% · elevated tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for ARROW INTL., INC.

The standout signal for ARROW INTL., INC. is Death-code intensity: 2.42% of 8,068 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ARROW INTL., INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 4,986 (61.8% of event_type total). Peak single-year volume reaches 970 reports across 23 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

8,068
Total Reports
195
Event-type Death
2,849
Injury Reports
20
Device Types

Event Types

Malfunction 4,986 (61.8%)
Injury 2,849 (35.3%)
Death 195 (2.4%)
24 (0.3%)
Other 14 (0.2%)

Patient Outcomes

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

4,471 (54.9%)
Required Intervention 2,789 (34.3%)
Other 567 (7.0%)
Death 213 (2.6%)
R 48 (0.6%)
Hospitalization 23 (0.3%)
O 13 (0.2%)
Life Threatening 7 (0.1%)
L 3 (0.0%)
Disability 3 (0.0%)
S 2 (0.0%)
H 1 (0.0%)

Yearly Trend

93
1993: 3
94
1994: 25
95
1995: 22
96
1996: 25
97
1997: 267
98
1998: 394
99
1999: 386
00
2000: 155
01
2001: 145
02
2002: 150
03
2003: 185
04
2004: 272
05
2005: 332
06
2006: 376
07
2007: 359
08
2008: 626
09
2009: 625
10
2010: 970
11
2011: 680
12
2012: 629
13
2013: 626
14
2014: 591
15
2015: 225