PlainHospital

ARROW INTERNATIONAL LLC

Manufacturer adverse-event records for ARROW INTERNATIONAL LLC 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 · 2020–2026 · mid-book · typical Death-code · injury-light

Injury-mix signature

ARROW INTERNATIONAL LLC is lighter on Injury codes

Injury-coded event_type share is 5.3% (injury-light tercile) beside 0.35% Death-coded (typical). Volume band: mid.

What the Injury-mix reading shows for ARROW INTERNATIONAL LLC

The standout signal for ARROW INTERNATIONAL LLC is Injury-mix: 5.3% Injury-coded (injury-light) beside 0.35% 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 LLC. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 20 device types, led in this extract by Malfunction at 11,518 (94.3% of event_type total). Peak single-year volume reaches 3,354 reports across 6 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

12,213
Total Reports
43
Event-type Death
652
Injury Reports
20
Device Types

Event Types

Malfunction 11,518 (94.3%)
Injury 652 (5.3%)
Death 43 (0.4%)

Patient Outcomes

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

11,763 (96.7%)
Required Intervention 226 (1.9%)
Death 38 (0.3%)
Other 37 (0.3%)
R 30 (0.2%)
Hospitalization 19 (0.2%)
L 13 (0.1%)
Life Threatening 12 (0.1%)
H 11 (0.1%)
D 5 (0.0%)
Disability 4 (0.0%)
O 3 (0.0%)
Congenital Anomaly 3 (0.0%)

Devices (20)

Device Reports
System, Balloon, Intra-Aortic And Control 3,260
Catheter, Percutaneous 2,920
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 2,315
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 896
Wire, Guide, Catheter 791
Catheter, Hemodialysis, Implanted 435
Catheter, Conduction, Anesthetic 285
Introducer, Catheter 276
Catheter, Hemodialysis, Non-Implanted 238
Catheter, Flow Directed 200
Catheter, Subclavian 128
Midline Catheter 122
Anesthesia Conduction Kit 58
Catheter, Electrode Recording, Or Probe, Electrode Recording 55
Kit, Repair, Catheter, Hemodialysis 41
Catheter, Hemodialysis, Triple Lumen, Non-Implanted 30
Catheter And Tip, Suction 26
Needle, Conduction, Anesthetic (W/Wo Introducer) 25
Catheter, Ultrasound, Intravascular 23
Epidural Anesthesia Kit 21

Yearly Trend

20
2020: 2
22
2022: 2,173
23
2023: 2,941
24
2024: 3,354
25
2025: 3,215
26
2026: 528

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