Arrow Intl., Inc.
FDA adverse event reports naming Arrow Intl., Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ARROW INTL., INC..
- Total reports
- 8,068
- Deaths
- 196
- Injuries
- 2,848
- Malfunctions
- 4,986
Reports per year
14501
15002
18503
27204
33205
37606
35907
62608
62509
97010
68011
62912
62613
59114
22515
Source: FDA adverse event reports by year received, 2001–2015. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Balloon, Intra-Aortic And ControlDSP4,314
- Catheter, Intravascular, DiagnosticDQO679
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ640
- Anesthesia Conduction KitCAZ412
- Catheter, PercutaneousDQY275
- Introducer, CatheterDYB273
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS212
- Catheter, Flow DirectedDYG199
- Catheter, EmbolectomyDXE174
- Catheter, Hemodialysis, ImplantedMSD164
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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