ARROW IPN030144Recalls & reported problems
Teleflex Incorporated · Arrowg+ard Blue(R) One-Lumen CVC · Class 2 · Implant
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10801902102291), received between Jun 14, 2023 and Feb 25, 2026 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (15 reports).
12 other recalls cover devices cleared under the same FDA submission (K900263); 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent15
- Deformation Due to Compressive Stress2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Migration1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Material Twisted/Bent
IT WAS REPORTED THAT "(B)(6) 2025, (B)(6) HOSPITAL, NEUROSURGERY DEPARTMENT; THE DOCTOR FOUND THE SWG 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 24442821 ↗MalfunctionFeb 25, 2026Crack
IT WAS REPORTED THAT "(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 24442486 ↗MalfunctionFeb 24, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2025, (B)(6) HOSPITAL, NEUROSURGERY DEPARTMENT, THE DOCTOR FOUND THE SWG 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 24430694 ↗MalfunctionFeb 24, 2026Material Twisted/Bent
IT WAS REPORTED THAT "ON (B)(6) 2025, (B)(6) HOSPITAL, NEUROSURGERY DEPARTMENT, THE DOCTOR FOUND THE SWG 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 24430340 ↗MalfunctionDec 29, 2025Unintended Movement; Migration; Unintended Movement; Migration
IT WAS REPORTED THAT "AFTER COMPLETED THE INSERTION, THE CATHETER DISLODGED DURING THE NIGHT. THEN THEY CHANGED ANOTHER ONE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23907114 ↗MalfunctionMay 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE SAME 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 22018318 ↗MalfunctionMay 14, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE SAME 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 22018258 ↗MalfunctionApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED "(B)(6) 2025, AFTER INSERTING THE CATHETER, THE PATIENT HAD AN ALLERGIC REACTION." ADDITIONAL INFORMATION RECEIVED REPORTS "THE ALLERGIC REACTION WAS CAUSED BY CHLOROHEXIDINE". THE USER CHANGED 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: Hypersensitivity/Allergic reaction
MAUDE report 21771661 ↗MalfunctionJan 16, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG KINKED PRIOR TO THE PATIENT". THEY CHANGED A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167491 ↗MalfunctionSep 10, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "DURING INSERTION, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT. THE CATHETER CAN'T GO THROUGH IT. IT CANNOT BE USED. NO HARM FOR 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 20179013 ↗MalfunctionSep 3, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "WHEN THE SWG INSERTED INTO THE ARS, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. 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 20130102 ↗MalfunctionAug 21, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED "(B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET. 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 20012653 ↗MalfunctionAug 13, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: (B)(6) 2024, DURING THE INSERTION, THE DOCTOR FOUND IT WAS EASY TO KINK DUE TO THE SWG WAS TOO SOFT. ALL 4 SWG WERE USED ON THE SAME PROCEDURE WITH THE SAME LOT NUMBER. THE PATIENT CONDITION IS FINE. THEY CHANGED TO A NEW ONE. NO MEDICAL INTERVENTION WAS PERFORMED. ASSOCIATED COMPLAINTS: 3006425876-2024-00798, 3006425876-2024-00797, 3006425876-2024-00790 AND 3006425876-2024-00775.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19970263 ↗MalfunctionAug 12, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT"12 JULY 2024, DURING THE INSERTION, THE DOCTOR FOUND IT WAS EASY TO KINKED DUE THE SWG TOO SOFT. ALL 4 SWG WERE USED ON THE SAME PROCEDURE WITH THE SAME LOT NUMBER. THE PATIENT CONDITION IS FINE. THEY CHANGED A NEW ONE. NO MEDICAL INTERVENTION WAS PERFORMED. ASSOCIATED COMPLAINTS: 3006425876-2024-00798, 3006425876-2024-00797, 3006425876-2024-00790 AND 3006425876-2024-00775.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19958798 ↗MalfunctionAug 12, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT"12 JULY 2024, DURING THE INSERTION, THE DOCTOR FOUND IT WAS EASY TO KINKED DUE THE SWG TOO SOFT. ALL 4 SWG WERE USED ON THE SAME PROCEDURE WITH THE SAME LOT NUMBER. THE PATIENT CONDITION IS FINE. THEY CHANGED A NEW ONE. NO MEDICAL INTERVENTION WAS PERFORMED. ASSOCIATED COMPLAINTS: 3006425876-2024-00798, 3006425876-2024-00797, 3006425876-2024-00790 AND 3006425876-2024-00775.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19958792 ↗MalfunctionMay 14, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: "18 APR 2024, IN ICU, THE DOCTOR FOUND THAT THE ARS WAS LEAKING DURING USE ON THE PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19309583 ↗MalfunctionJan 25, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT: (B)(6) 2023, THE RESISTANCE WAS FOUND WHEN THE SWG INSERT INTO THE ARS DURING USED ON THE PATIENT. THE PATIENT WAS REPORTED AS FINE. THE RETURNED DEVICE SHOWED THAT THE DEVICE WAS KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18581108 ↗MalfunctionDec 6, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT (B)(6) 2023, THE SWG WAS FOUND KINKED DURING USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18274636 ↗MalfunctionJun 14, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED DURING USE ON THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132207 ↗MalfunctionJun 14, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED DURING USE ON THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17132199 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K900263. One submission often covers many models, so check the product and lot details in each record.
- Z-2376-2026 · Apr 21, 2026 · Open, ClassifiedDescription/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-12123-F; CVC KIT: 3-LUMEN 12 FR X 20 CM/AK-15123-F; 3L CVC KIT: 7 FR X 16 CM/ASK-
- Z-0053-2020 · May 17, 2019 · TerminatedPediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous acces
- Z-2886-2018 · Jul 3, 2018 · TerminatedPediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous acc
- Z-1984-2018 · Apr 11, 2018 · TerminatedSingle-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
- Z-1985-2018 · Apr 11, 2018 · TerminatedARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
- Z-1333-2018 · Dec 22, 2017 · TerminatedARROWg+ard Blue CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheter
- Z-1001-2018 · Nov 27, 2017 · TerminatedARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or condi
- Z-2337-2017 · May 9, 2017 · TerminatedARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
- Z-1830-2012 · May 3, 2012 · TerminatedArrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circ
- Z-2496-2010 · Jul 29, 2010 · TerminatedTwo-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
- Z-1499-2009 · Feb 11, 2009 · TerminatedArrow ARROWg+ard CVCs (Central Venous Catheters)
- Z-0082-04 · Sep 16, 2003 · TerminatedArrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.