ARROW IPN036226Recalls & reported problems
Teleflex Incorporated · Marked Spring-Wire Guide with Arrow Advancer(TM) Maximum OD per ISO 11070 is 0.82 mm. · Class 2
All models of ARROW (1494)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902122497), received between Oct 3, 2023 and Oct 3, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (5 reports).
1 other recall cover devices cleared under the same FDA submission (K914531); 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.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
CUSTOMER REPORTED GUIDEWIRES KINKED DURING IJ INSERTION AND HAD TO GO THROUGH 5 WIRES BEFORE INSERTION WAS SUCCESSFUL. THE SIXTH GUIDEWIRE WAS SUCCESSFULLY USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860442 ↗MalfunctionOct 3, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
CUSTOMER REPORTED GUIDEWIRES KINKED DURING IJ INSERTION AND HAD TO GO THROUGH 5 WIRES BEFORE INSERTION WAS SUCCESSFUL. THE SIXTH GUIDEWIRE WAS SUCCESSFULLY USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860410 ↗MalfunctionOct 3, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
CUSTOMER REPORTED GUIDEWIRES KINKED DURING IJ INSERTION AND HAD TO GO THROUGH 5 WIRES BEFORE INSERTION WAS SUCCESSFUL. THE SIXTH GUIDEWIRE WAS SUCCESSFULLY USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860340 ↗MalfunctionOct 3, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
CUSTOMER REPORTED GUIDEWIRES KINKED DURING IJ INSERTION AND HAD TO GO THROUGH 5 WIRES BEFORE INSERTION WAS SUCCESSFUL. THE SIXTH GUIDEWIRE WAS SUCCESSFULLY USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860310 ↗MalfunctionOct 3, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
CUSTOMER REPORTED GUIDEWIRES KINKED DURING IJ INSERTION AND HAD TO GO THROUGH 5 WIRES BEFORE INSERTION WAS SUCCESSFUL. THE SIXTH GUIDEWIRE WAS SUCCESSFULLY USED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860248 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K914531. One submission often covers many models, so check the product and lot details in each record.
- Z-3299-2024 · Jul 26, 2024 · Open, ClassifiedArrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray
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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