ARROW IPN030312Recalls & reported problems
Teleflex Incorporated · Arterial Catheterization Set · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801902102751), received between Jun 26, 2023 and Mar 24, 2025 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (6 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent6
- Deformation Due to Compressive Stress5
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "TIP OF THE GUIDE WIRE WAS BENT.". THE PATIENT HAD NO HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21675852 ↗MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "DURING INSPECTION, BEFORE THE PROCEDURE, IT WAS OBSERVED THAT THE CATHETER GUIDE WIRE WAS TORTUOUS." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20460357 ↗MalfunctionOct 16, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "THE HEALTH CARE PROVIDER FOUND OUT WIRE WAS BENT BEFORE USE ON PATIENT." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20459739 ↗MalfunctionMar 29, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: "THE HCP FOUND CATHETER KINKED PRIOR TO USE ON PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19002485 ↗MalfunctionMar 28, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE KINKED PRIOR TO USE ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18993115 ↗MalfunctionMar 28, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: "THE CATHETER WAS FOUND TO BE KINKED PRIOR TO USE ON PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18992988 ↗MalfunctionOct 9, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
THE SWG WAS FOUND TO BE KINKED PRIOR TO USE ON PATIENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17893941 ↗MalfunctionAug 8, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED "GUIDE WIRE IS BENT" PRIOR TO PATIENT USE. A NEW DEVICE WAS OBTAINED FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17482037 ↗MalfunctionJul 12, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THE GUIDEWIRE WAS BENT INSIDE THE PACKAGING. NO PATIENT INVOLVEMENT WITH DEVICE WAS REPORTED. A NEW KIT WAS OBTAINED FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17308989 ↗MalfunctionJul 12, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THE GUIDEWIRE WAS BENT INSIDE THE PACKAGING. NO PATIENT INVOLVEMENT WITH DEVICE WAS REPORTED. A NEW KIT WAS OBTAINED FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17308868 ↗MalfunctionJun 26, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED "AFTER OPENING THE KIT, IT WAS OBSERVED THAT THE GUIDE WIRE AND THE PUNCTURE NEEDLE ARE MISALIGNED (CROOKED). IT WAS NECESSARY TO OPEN A NEW ONE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17197766 ↗
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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