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 5.1% (injury-light tercile) beside 0.32% 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: 5.1% Injury-coded (injury-light) beside 0.32% 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 12,896 (94.6% 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.

13,638
Total Reports
44
Event-type Death
698
Injury Reports
20
Device Types

Event Types

Malfunction 12,896 (94.6%)
Injury 698 (5.1%)
Death 44 (0.3%)

Patient Outcomes

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

13,085 (96.8%)
Required Intervention 243 (1.8%)
Other 40 (0.3%)
Death 39 (0.3%)
R 31 (0.2%)
Hospitalization 20 (0.1%)
L 13 (0.1%)
H 12 (0.1%)
Life Threatening 12 (0.1%)
Disability 7 (0.1%)
D 5 (0.0%)
O 3 (0.0%)
Congenital Anomaly 3 (0.0%)

Devices (20)

Device Reports
System, Balloon, Intra-Aortic And Control 3,797
Catheter, Percutaneous 3,139
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 2,437
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days 928
Wire, Guide, Catheter 794
Catheter, Hemodialysis, Implanted 456
Catheter, Conduction, Anesthetic 367
Introducer, Catheter 286
Catheter, Hemodialysis, Non-Implanted 253
Catheter, Flow Directed 206
Catheter, Subclavian 129
Midline Catheter 122
I.V. Start Kit 99
Anesthesia Conduction Kit 66
Catheter, Electrode Recording, Or Probe, Electrode Recording 58
Peripheral Catheter Insertion Kit 55
Catheter Introducer Kit 52
Kit, Repair, Catheter, Hemodialysis 42
Multi-Lumen Hemodialysis Catheterization Kit 41
Catheter Guide Wire Kit 40

Yearly Trend

20
2020: 2
22
2022: 2,173
23
2023: 2,941
24
2024: 3,354
25
2025: 3,216
26
2026: 1,952

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