PlainHospital

ARROW INTERNATIONAL INC.

Manufacturer adverse-event records for ARROW INTERNATIONAL 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 · 1992–2025 · mid-book · elevated Death-code · injury-light

Injury-mix signature

ARROW INTERNATIONAL INC. is lighter on Injury codes

Injury-coded event_type share is 5.7% (injury-light tercile) beside 0.74% Death-coded (elevated). Volume band: mid.

What the Injury-mix reading shows for ARROW INTERNATIONAL INC.

The standout signal for ARROW INTERNATIONAL INC. is Injury-mix: 5.7% Injury-coded (injury-light) beside 0.74% Death-coded, on a mid-book footprint.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ARROW INTERNATIONAL 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 14,694 (93.5% of event_type total). Peak single-year volume reaches 3,082 reports across 34 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

15,715
Total Reports
117
Event-type Death
899
Injury Reports
20
Device Types

Event Types

Malfunction 14,694 (93.5%)
Injury 899 (5.7%)
Death 117 (0.7%)
3 (0.0%)
Other 2 (0.0%)

Patient Outcomes

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

14,462 (91.1%)
Required Intervention 840 (5.3%)
Other 189 (1.2%)
R 138 (0.9%)
Death 126 (0.8%)
Life Threatening 43 (0.3%)
Hospitalization 38 (0.2%)
O 23 (0.1%)
L 10 (0.1%)
Disability 6 (0.0%)
H 3 (0.0%)
S 3 (0.0%)
Invalid Data 1 (0.0%)

Devices (20)

Device Reports
Catheter, Percutaneous 3,691
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 2,800
System, Balloon, Intra-Aortic And Control 2,742
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 1,266
Anesthesia Conduction Kit 928
Catheter, Conduction, Anesthetic 909
Wire, Guide, Catheter 760
Introducer, Catheter 690
Catheter, Hemodialysis, Implanted 346
Catheter, Embolectomy 275
Epidural Anesthesia Kit 243
Catheter, Hemodialysis, Non-Implanted 192
Catheter, Flow Directed 160
Catheter, Intravascular, Diagnostic 144
Catheter, Subclavian 120
Catheter And Tip, Suction 92
Catheter, Ultrasound, Intravascular 52
Catheter, Electrode Recording, Or Probe, Electrode Recording 49
Kit, Repair, Catheter, Hemodialysis 24
Midline Catheter 24

Yearly Trend

92
1992: 3
93
1993: 3
94
1994: 4
95
1995: 1
96
1996: 4
97
1997: 4
98
1998: 7
99
1999: 1
00
2000: 7
01
2001: 4
02
2002: 4
03
2003: 4
04
2004: 4
05
2005: 6
06
2006: 7
07
2007: 12
08
2008: 96
09
2009: 201
10
2010: 142
11
2011: 143
12
2012: 85
13
2013: 257
14
2014: 452
15
2015: 1,067
16
2016: 1,727
17
2017: 1,752
18
2018: 1,940
19
2019: 3,082
20
2020: 2,200
21
2021: 2,136
22
2022: 335
23
2023: 14
24
2024: 9
25
2025: 2

Read our methodology - how this data is sourced, computed, and verified.