ARROW IPN037073Recalls & reported problems
Teleflex Incorporated · Arterial Catheterization Kit · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20801902120223), received between Jan 30, 2023 and Jan 30, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K021120); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2023Material Separation; Material Separation
IT WAS REPORTED "CATHETER BROKE OFF IN PATIENT". A MEDICAL INTERVENTION WAS REQUIRED TO HAVE THE CATHETER REMOVED AND THERAPY WAS DELAYED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE FINE.
Patient problems: Foreign Body In Patient
MAUDE report 16263636 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021120. One submission often covers many models, so check the product and lot details in each record.
- Z-2377-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
- Z-1973-2018 · Apr 11, 2018 · TerminatedRadial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04120-HF
Other Wire, guide, catheter devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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