ARROW IPN929007Recalls & reported problems
Teleflex Incorporated · Arrowg+ard Blue(R) Two-Lumen CVC
Quick summary
This Arrow two-lumen central venous catheter (Arrowgard Blue) is used to place lines into large veins. The 65 reports mostly describe the catheter material twisting or bending during insertion, plus some cracking and separation of parts, and occasionally a broken needle hub or a stiff, bendy wire guide. No deaths and 1 injury were reported. No recalls name this device. All 65 reports came in the past 12 months, with none in the prior12 months.
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
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10801902217551), received between Dec 22, 2025 and Sep 23, 2026 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (39 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/Bent39
- Crack6
- Deformation Due to Compressive Stress2
- Difficult to Remove2
- Fluid/Blood Leak2
- Material Deformation2
- Material Separation2
- Physical Resistance/Sticking2
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- Skin Tears1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Deformation Due to Compressive Stress; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871783 ↗MalfunctionJul 6, 2026Deformation Due to Compressive Stress
IT WAS REPORTED THAT DURING INITIAL INSERTION OF A CENTRAL VENOUS CATHETER (CVC), THE OPERATING PHYSICIAN OBSERVED THAT THE SPRING WIRE GUIDE (SWG) BECAME BENT WHILE BEING ADVANCED THROUGH THE INTRODUCER NEEDLE. THE KINK WAS REPORTED TO BE LOCATED NEAR THE DISTAL END AT THE J-TIP CURVE. AS A RESULT, THE PROCEDURE WAS DELAYED. THE AFFECTED DEVICE WAS REMOVED FROM USE AND REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT OTHER THAN A DELAY IN THERAPY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25727643 ↗MalfunctionJul 6, 2026Fracture
IT WAS REPORTED THAT DURING INITIAL INSERTION OF A CENTRAL VENOUS CATHETER (CVC), THE OPERATING PHYSICIAN OBSERVED THE INTRODUCER NEEDLE HUB TO BE BROKEN. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." THE AFFECTED DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725724 ↗MalfunctionJun 15, 2026Material Twisted/Bent
IT WAS REPORTED THAT AN "INFUSION LINE TENDED TO KINK EASILY AND RETAIN ITS BEND." ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROCEDURE WAS COMPLETED AFTER RESTORING THE LINE TO ITS CORRECT POSITION. NO PATIENT INJURY, ADVERSE CLINICAL CONSEQUENCES, OR MEDICAL INTERVENTION WERE REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512041 ↗MalfunctionMay 19, 2026Material Twisted/Bent
IT WAS REPORTED THAT "DURING THE PROCEDURE, THE OPERATING PHYSICIAN FOUND GUIDEWIRE BENT. THE PHYSICIAN OPENED UP A NEW KIT TO FINISH THE PROCEDURE." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE REPLACEMENT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25217548 ↗MalfunctionMay 14, 2026Fluid/Blood Leak
IT WAS REPORTED THAT ON (B)(6) 2026, THE CATHETER WAS OBSERVED TO BE LEAKING DURING USE ON THE SECOND DAY FOLLOWING INSERTION. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25176319 ↗MalfunctionMay 11, 2026Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2026, DURING THE INITIAL INSERTION OF A CENTRAL VENOUS CATHETER (CVC), THE GUIDEWIRE WAS FOUND TO BE KINKED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE". NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED BEYOND REMOVAL OF THE AFFECTED DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING REPLACEMENT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142450 ↗MalfunctionMay 8, 2026Crack
IT WAS REPORTED THAT, "DURING THE PROCEDURE, THE OPERATING PHYSICIAN OBSERVED A "SPLIT/CRACK" ON THE INTRODUCER NEEDLE CANNULA." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED AFTER CHANGING TO ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128352 ↗MalfunctionMay 4, 2026Crack
IT WAS REPORTED THAT "ON (B)(6) 2026, A CENTRAL VENOUS CATHETERIZATION WAS PERFORMED BY A PHYSICIAN AT THE BEDSIDE UNDER ASEPTIC TECHNIQUE. AFTER ROUTINE SKIN DISINFECTION, THE PUNCTURE WAS COMPLETED SMOOTHLY, AND THE GUIDEWIRE WAS INSERTED SUCCESSFULLY. HOWEVER, THE TIP OF THE DILATOR CRACKED DURING SKIN DILATION. ANOTHER CENTRAL VENOUS CATHETER KIT WAS USED, AND SKIN DILATION WAS PERFORMED SMOOTHLY WITH THE NEW DILATOR. THE CATHETERIZATION WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONDITIONS WERE OBSERVED IN THE PATIENT AFTER THE PROCEDURE." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR MEDICAL INTERVENTION ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074805 ↗MalfunctionMay 4, 2026Material Twisted/Bent
IT WAS REPORTED THAT DURING PATIENT USE, "THE DILATOR BENT." THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE. NO MEDICAL INTERVENTION WAS NECESSARY, AND THE PROCEDURE WAS COMPLETED AFTER SWITCHING TO AN ALTERNATE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25067686 ↗MalfunctionApr 17, 2026Material Deformation
IT WAS REPORTED THAT "(B)(6) 2026, EMERGENCY DEPARTMENT OF (B)(6) FOUND THAT THE TIP OF THE DILATOR WAS DEFORMED DURING CATHETERIZATION, MAKING IT IMPOSSIBLE TO PUNCTURE NORMALLY. A NEW CATHETER WAS SUCCESSFULLY REPLACED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24910515 ↗MalfunctionApr 17, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2026, AT THE CARDIOVASCULAR CARE UNIT (CCU) OF (B)(6) HOSPITAL, KINKING AND DEFORMATION OF THE GUIDEWIRE WERE NOTED DURING CATHETER PLACEMENT. ATTEMPTS TO MANIPULATE AND USE THE DEVICE WERE UNSUCCESSFUL, AND THE CATHETER COULD NOT BE INSERTED. DUE TO THE PATIENT'S INFECTIOUS DISEASE STATUS, THE PROBLEMATIC CATHETER WAS DISCARDED PER THE DEPARTMENT'S PROTOCOL. A NEW CATHETER WAS THEN USED, AND SUCCESSFUL PLACEMENT WAS ACHIEVED WITHOUT FURTHER ISSUES." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24910437 ↗MalfunctionApr 16, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2026 AT 10:41, A CENTRAL VENOUS CATHETER WAS INSERTED AND USED NORMALLY. HOWEVER, DURING THE DELIVERY OF THE GUIDEWIRE, IT WAS FOUND TO BE KINKED AND UNABLE TO BE INSERTED. A NEW CENTRAL VENOUS CATHETER WAS REPLACED AND RE INSERTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED". THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24904186 ↗MalfunctionApr 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2026, THE NURSE REPORTED THAT THE SWG WAS FOUND KINKED AND CAUSED THE INSERTION WAS NOT SMOOTHLY." THE INSERTION FAILED. THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844941 ↗MalfunctionApr 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2026, THE NURSE REPORTED THAT THE SWG WAS FOUND KINKED AND CAUSED THE INSERTION WAS NOT SMOOTHLY." THE INSERTION FAILED. THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844637 ↗MalfunctionApr 10, 2026Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2026, THE NURSE REPORTED THAT THE SWG WAS FOUND KINKED AND CAUSED THE INSERTION WAS NOT SMOOTHLY." THE INSERTION FAILED. THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839329 ↗MalfunctionApr 9, 2026Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2026, THE NURSE REPORTED THAT THE SWG WAS FOUND KINKED." THE INSERTION WAS NOT SUCCESSFUL. THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24831167 ↗MalfunctionApr 9, 2026Crack
IT WAS REPORTED THAT "ON (B)(6) 2026, THE NEEDLE HUB WAS FOUND CRACKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829838 ↗MalfunctionApr 8, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2026, IN EMERGENCY INTERNAL MEDICINE, DURING THE INSERTION, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815689 ↗MalfunctionApr 7, 2026Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2026, THE DOCTOR OPEN THE PACKAGE AND FOUND THE SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24803784 ↗MalfunctionApr 7, 2026Difficult to Remove; Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2025, THE PATIENT REQUIRED SUBCLAVIAN DEEP VENOUS CATHETERIZATION DUE TO THEIR CONDITION. DURING CATHETER INSERTION, THE GUIDEWIRE COULD NOT BE WITHDRAWN. SUBSEQUENT INVESTIGATION REVEALED THAT THE GUIDEWIRE WAS KINKED AND HAD HOOKED INTO THE SUBCUTANEOUS TISSUE, PREVENTING REMOVAL. A SMALL AMOUNT OF SKIN AND SUBCUTANEOUS TISSUE WAS EXCISED, AFTER WHICH THE GUIDEWIRE WAS SUCCESSFULLY REMOVED." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: Skin Tears
MAUDE report 24802003 ↗MalfunctionMar 30, 2026Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2026, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT". THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731313 ↗MalfunctionMar 30, 2026Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2026, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT". THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728857 ↗MalfunctionMar 23, 2026Break; Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2026, DUE TO DIFFICULTY IN PERIPHERAL VENOUS PUNCTURE, CENTRAL VENOUS PUNCTURE WAS INDICATED. THE PATIENT HAD A SHORT AND THICK NECK, SO THE RIGHT SUBCLAVIAN VEIN WAS SELECTED FOR PUNCTURE. DURING THE PUNCTURE, THE PUNCTURE NEEDLE BENT; IT WAS WITHDRAWN IMMEDIATELY, AND THE NEEDLE TIP BROKE. A NEW CENTRAL VENOUS CATHETER WAS REPLACED PROMPTLY. NO HARM WAS CAUSED TO THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661333 ↗MalfunctionMar 11, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2026, THE SWG WAS FOUND KINKED DURING INSERTION. THEY CHANGED TO A NEW ONE TO RESOLVE THE ISSUE." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24568490 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.