ARROW IPN029681Recalls & reported problems
Teleflex Incorporated · Arterial Catheterization Set · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Arrow arterial catheterization set is used to place a catheter in an artery. The 26 reports mostly describe guide wires found bent or kinked when unpacked or inspected, with no patient involvement. There are no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10801902144062), received between Apr 19, 2021 and Aug 11, 2025 — classified as 26 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (22 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent22
- Deformation Due to Compressive Stress3
- Material Deformation2
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "THE KIT HAD A KINKED WIRE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION CAN NOT BE PROVIDED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22772135 ↗MalfunctionJul 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "INCIDENT OCCURRED ON 09 APRIL 2025. THE DOCTOR FACING THE GUIDE WIRE INSIDE THE PACKING COMES DAMAGED ALL THE TIME." THIS WAS FOUND PRIOR TO USE. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00589, 3006425876-2025-00588, 3006425876-2025-00601, 3006425876-2025-00587, AND 3006425876-2025-00586
Patient problems: Insufficient Information
MAUDE report 22411658 ↗MalfunctionJul 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "INCIDENT OCCURRED ON (B)(6) 2025. THE DOCTOR FACING THE GUIDE WIRE INSIDE THE PACKING COMES DAMAGED ALL THE TIME." THIS WAS FOUND PRIOR TO USE. THERE WERE 2 UNITS FROM THIS LOT THAT WAS FOUND KINKED DURING UNPACKING. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00589, 3006425876-2025-00601, 3006425876-2025-00587, AND 3006425876-2025-00586.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411435 ↗MalfunctionOct 24, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "IT WAS FOUND THAT THE GUIDE WIRE IS BENT, BEFORE USE ON PATIENT." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20523006 ↗MalfunctionAug 20, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: "DURING THE PRODUCT RECEIPT AND LABELING INSPECTION, WE DISCOVERED A DAMAGED PACKAGE AND THE CATHETER AND SWG WERE KINKED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20006486 ↗MalfunctionJun 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: "SAC CATHETER WAS KINKED BEFORE USE ON PATIENT." THE RETURNED DEVICE SHOWED THAT THE SWG WAS KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508091 ↗MalfunctionJun 11, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT, "DURING THE RECEIPT AND LABELING INSPECTION, WE FOUND THE PRODUCT WITH DAMAGED PACKAGING (CRUSHED) INSIDE THE BOX". THE PHOTO SHOWS THAT THE SWG IS KINKED. ASSOCIATED COMPLAINTS 3006425876-2024-00569 AND 3006425876-2024-00580.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19507955 ↗MalfunctionJun 11, 2024Device Damaged Prior to Use; Material Twisted/Bent; Device Damaged Prior to Use; Material Twisted/Bent
IT WAS REPORTED THAT " DURING THE RECEIPT AND LABELING INSPECTION, WE FOUND THE PRODUCT WITH DAMAGED PACKAGING (CRUSHED) INSIDE THE BOX". THE PHOTO SHOWS THAT THE SWG IS KINKED. ASSOCIATED COMPLAINTS 3006425876-2024-00580.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19507894 ↗MalfunctionJun 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED " ACCORDING TO A MEDICAL REPORT, WHEN OPENING THE PACKAGING OF THE RADIAL ARTERIAL CATHETER, IT WAS FOUND TO BE COMPLETELY TORTUOUS, INVALIDATING ITS USE". THIS WAS FOUND PRIOR TO USE. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19466607 ↗MalfunctionApr 8, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: DURING THE RECEIPT AND LABELING INSPECTION WE FOUND THE PRODUCT AND PACKAGING DAMAGED (DENTED) INSIDE THE BOX." THE RETURNED SAMPLES WERE FOUND TO HAVE KINKED GUIDEWIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19057531 ↗MalfunctionMar 21, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE HCP FOUND CATHETER KINKED PRIOR TO USE ON PATIENT. THE RETURNED DEVICE SHOWED THAT THE SWG WAS KINKED NOT THE CATHETER. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18948041 ↗MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " WE FOUND THE PRODUCT AND PACKAGING DAMAGED CRUSHED INSIDE THE BOX DURING THE RECEIPT AND LABELING INSPECTION". THIS OCCURED PRIOR TO USE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921150 ↗MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " WE FOUND THE PRODUCT AND PACKAGING DAMAGED CRUSHED INSIDE THE BOX DURING THE RECEIPT AND LABELING INSPECTION". THIS OCCURED PRIOR TO USE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920435 ↗MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " WE FOUND THE PRODUCT AND PACKAGING DAMAGED CRUSHED INSIDE THE BOX DURING THE RECEIPT AND LABELING INSPECTION". THIS OCCURED PRIOR TO USE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920406 ↗MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " WE FOUND THE PRODUCT AND PACKAGING DAMAGED CRUSHED INSIDE THE BOX DURING THE RECEIPT AND LABELING INSPECTION". THIS OCCURED PRIOR TO USE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920399 ↗MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " WE FOUND THE PRODUCT AND PACKAGING DAMAGED CRUSHED INSIDE THE BOX DURING THE RECEIPT AND LABELING INSPECTION". THIS OCCURED PRIOR TO USE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920393 ↗MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " WE FOUND THE PRODUCT AND PACKAGING DAMAGED CRUSHED INSIDE THE BOX DURING THE RECEIPT AND LABELING INSPECTION". THIS OCCURED PRIOR TO USE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920381 ↗MalfunctionMar 18, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " WE FOUND THE PRODUCT AND PACKAGING DAMAGED CRUSHED INSIDE THE BOX DURING THE RECEIPT AND LABELING INSPECTION". THIS OCCURED PRIOR TO USE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18920376 ↗MalfunctionMar 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: "DURING THE RECEIPT AND LABELING INSPECTION WE FOUND THE PRODUCT AND PACKAGING DAMAGED (DENTED) INSIDE THE BOX." THE RETURNED SWG SAMPLE WAS KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18914092 ↗MalfunctionMar 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: THE SWG WAS FOUND TO BE KINKED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18876021 ↗MalfunctionMar 8, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " SGW WAS KINKED PRIOR TO PATIENT USE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18864745 ↗MalfunctionFeb 12, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "WE FOUND THE PRODUCT WITH DAMAGED PACKAGING INSIDE THE BOX DURING RECEIPT AND LABELLING INSPECTION." THE ISSUE WAS IDENTIFIED AT INCOMING INSPECTION /INVENTORY REVIEW. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18683485 ↗MalfunctionDec 4, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT: BENT CATHETER INSIDE THE BOX. DEFECT FOUND DURING PRODUCT INSPECTION AND LABELING. INSPECTION OF THE RETURNED DEVICE SHOWS THAT THE SWG WAS KINKED, MAKING COMPLAINT REPORTABLE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18255450 ↗MalfunctionSep 21, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT: THE WIRE WAS FOUND TO BE KINKED. IT WAS FOUND DURING PRODUCT PREPARATION BEFORE USE ON A PATIENT. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17786985 ↗MalfunctionJun 26, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED PRIOR TO PATIENT USE "AT THE MOMENT OF PASSING THE CATHETER, A FRACTURED GUIDE IS EVIDENT, SO IT IS NECESSARY TO REQUEST A NEW CATHETER". THE GUIDE WAS "FOLDED". NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17198657 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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