ARROW IPN029682Recalls & reported problems
Teleflex Incorporated · Arterial Catheterization Set · Class 2
Quick summary
This Teleflex arterial catheterization set is used to place lines into a patient's artery. Most of the 47 reports describe the catheter or its guidewire arriving kinked, twisted or bent, so staff found the set unusable and replaced it before touching the patient. There are no deaths and no injuries, and 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
- 47
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10801902144079), received between Dec 14, 2021 and May 19, 2026 — classified as 47 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (33 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/Bent33
- Deformation Due to Compressive Stress12
- Break1
- Device Damaged Prior to Use1
- Material Integrity Problem1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2026Device Damaged Prior to Use; Material Twisted/Bent
IT WAS REPORTED THAT "UPON OPENING THE PRODUCT DURING PRODUCT PREPARATION, THE PROTECTIVE GUARD, EXTENSION LINE AND GUIDEWIRE WERE FOUND TO BE KINKED/BENT." IT WAS REPORTED THAT THE EVENT OCCURRED PRIOR TO USE ON THE PATIENT. THE DEVICE WAS NOT USED. THERE WERE NO PATIENT INVOLVEMENT AND NO ADVERSE PATIENT IMPACT OR INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219682 ↗MalfunctionFeb 23, 2026Material Twisted/Bent
IT WAS REPORTED THAT "BEFORE A LINE PROCEDURE, AS SOON AS TAKING OUT CATHETER FROM THE BOX, WIRE WAS KINKED AND REPLACED IT WITH ANOTHER PRODUCT." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415030 ↗MalfunctionJan 15, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON DECEMBER 17, AN A-LINE CATHETER PROCEDURE WAS PLANNED IN THE INTENSIVE CARE UNIT; HOWEVER, THE WIRE WAS FOUND TO BE KINKED AND UNUSABLE. THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE, AND THE PRODUCT WAS REPLACED WITH A NEW ONE FOR THE PROCEDURE." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24079741 ↗MalfunctionJan 7, 2026Material Twisted/Bent
IT WAS REPORTED THAT "DURING THE PRE-USE INSPECTION, IT WAS FOUND THAT THE CATHETER PART WAS KINKED." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988737 ↗MalfunctionSep 29, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "IT WAS FOUND THAT THE GUIDEWIRE WAS BENT/KINKED DURING PRODUCT PREP/PRETEST." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23166606 ↗MalfunctionAug 25, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "CATHETER HAD A BENT GUIDE WIRE, RENDERING IT UNUSABLE." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS COULD NOT BE PROVIDED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22883182 ↗MalfunctionJul 10, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE INTENSIVIST FACING THE GUIDE WIRE AND CATHETER BOTH INSIDE THE PACKING COMES DAMAGED ALL THE TIME. " THIS WAS FOUND PRIOR TO USE DURING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22469043 ↗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 WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00589, 3006425876-2025-00588, 3006425876-2025-00601 AND 3006425876-2025-00587.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411879 ↗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 3 UNITS FROM THIS LOT THAT WAS FOUND KINKED DURING UNPACKING. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00589, 3006425876-2025-00588, 3006425876-2025-00601, 3006425876-2025-00587, AND 3006425876-2025-00586.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411834 ↗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. THERE WERE 3 UNITS FROM THIS LOT THAT WAS FOUND KINKED DURING UNPACKING. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00589, 3006425876-2025-00588, 3006425876-2025-00601, 3006425876-2025-00587, AND 3006425876-2025-00586.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22411788 ↗MalfunctionMay 9, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "IT WAS FOUND THAT THE WIRE IS BENT, PRIOR TO USE ON PATIENT." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21995474 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: "THE GUIDE WIRE WAS FOUND BENT/KINKED PRIOR TO USE ON PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609850 ↗MalfunctionOct 9, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "IT WAS FOUND THAT THE WIRE IS BENT, PRIOR TO USE ON PATIENT." THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409081 ↗MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " DURING OUR LABELING PROCESS IT WAS DISCOVERED SEVEN UNITS THAT WERE BENT." THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-00884, 3006425876-2024-00898, 3006425876-2024-00897, 3006425876-2024-00896, 3006425876-2024-00895, 3006425876-2024-00894.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189858 ↗MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "DURING OUR LABELING PROCESS IT WAS DISCOVERED SEVEN UNITS THAT WERE BENT." THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-00884, 3006425876-2024-00898, 3006425876-2024-00897, 3006425876-2024-00896, 3006425876-2024-00895, 3006425876-2024-00893.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189718 ↗MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "DURING OUR LABELING PROCESS IT WAS DISCOVERED SEVEN UNITS THAT WERE BENT." THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-00884, 3006425876-2024-00898, 3006425876-2024-00897, 3006425876-2024-00896, 3006425876-2024-00894, 3006425876-2024-00893.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189680 ↗MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " DURING OUR LABELING PROCESS IT WAS DISCOVERED SEVEN UNITS THAT WERE BENT." THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-00884, 3006425876-2024-00898, 3006425876-2024-00897, 3006425876-2024-00896, 3006425876-2024-00895, 3006425876-2024-00894, 3006425876-2024-00893.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189669 ↗MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " DURING OUR LABELING PROCESS IT WAS DISCOVERED SEVEN UNITS THAT WERE BENT." THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-00884, 3006425876-2024-00898, 3006425876-2024-00897, 3006425876-2024-00896, 3006425876-2024-00895, 3006425876-2024-00894, 3006425876-2024-00893.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189652 ↗MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT " DURING OUR LABELING PROCESS IT WAS DISCOVERED SEVEN UNITS THAT WERE BENT." THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-00884, 3006425876-2024-00898, 3006425876-2024-00897, 3006425876-2024-00896, 3006425876-2024-00895, 3006425876-2024-00894, 3006425876-2024-00893.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189564 ↗MalfunctionSep 11, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "DURING OURS LABELING PROCESS WAS DISCOVERED SEVEN UNITS THAT WERE BENT." THERE WAS NO PATIENT INVOLVEMENT. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-00898, 3006425876-2024-00897, 3006425876-2024-00896, 3006425876-2024-00895, 3006425876-2024-00894, 3006425876-2024-00893.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20189475 ↗MalfunctionAug 15, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "GUIDEWIRE WAS TWISTED AND CATHETER WAS REPLACED". THE ISSUE WAS IDENTIFIED PRIOR TO USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990202 ↗MalfunctionAug 8, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: "THE HCP FOUND THE SWG WAS KINKED BEFORE USE ON PATIENT."
Patient problems: Insufficient Information
MAUDE report 19937817 ↗MalfunctionJul 9, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "THE HCP FOUND GUIDEWIRE HAS A KINK DURING USE ON PATIENT." THERE WAS NO MEDICAL INTERVENTIONS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".
Patient problems: Insufficient Information
MAUDE report 19702768 ↗MalfunctionJun 2, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE GUIDEWIRE IS NOT STRAIGHT RATHER BENT." THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19444855 ↗MalfunctionJun 2, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE GUIDEWIRE IS NOT STRAIGHT RATHER BENT." THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19444854 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.