ARROW IPN030162Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 00801902102324), received between Jan 29, 2021 and Mar 30, 2026 — classified as 3 injuries, 160 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (58 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Obstruction of Flow

  IT WAS REPORTED THAT "THE WHITE HUB EXHIBITED POOR FLOW IMMEDIATELY AFTER PLACEMENT AND BECAME COMPLETELY BLOCKED/OCCLUDED LATER THAT AFTERNOON". 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 24728641 ↗
• MalfunctionMar 9, 2026Failure to Advance

  IT WAS REPORTED THAT "THE GUIDE WIRE COULD GET NOT THROUGH THE ARS." 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 24546171 ↗
• MalfunctionMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "THE DEFECTIVE PRODUCT CAUSED REDNESS, SWELLING, AND ALLERGIC REACTIONS IN PATIENTS DURING PLACEMENT." THE SYMPTOMS WERE RESOLVED AFTER REMOVAL. 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 "SAFE".

  Patient problems: Hypersensitivity/Allergic reaction; Rash; Swelling/ Edema

  MAUDE report 24518818 ↗
• MalfunctionFeb 24, 2026Material Twisted/Bent

  IT WAS REPORTED THAT " GUIDE WIRE BENT". 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 24428771 ↗
• MalfunctionFeb 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE BENT." 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 24344166 ↗
• MalfunctionFeb 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE BENT." 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 24344151 ↗
• MalfunctionJan 21, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE DILATOR FAILED TO PENETRATE THE SUBCUTANEOUS ISSUE. WHEN I CHECKED WHETHER OR NOT TO USE GUIDEWIRE, IT WAS SAID TO HAVE BEEN USED, AND WHEN I TOOK IT OUT, IT WAS SAID THAT THE GUIDEWIRE WAS BENT. SO, THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." ADDITIONAL INFORMATION RECEIVED STATES " ACCORDING TO THE USER, THE GUIDEWIRE WAS USED DURING THE PROCEDURE, AND UPON REMOVAL FROM THE PATIENT'S BODY, IT WAS OBSERVED TO BE BENT. THE USER ALSO REPORTED THAT THE INITIAL ATTEMPT WAS UNSUCCESSFUL IN PENETRATING THE SUBCUTANEOUS LAYER, AFTER WHICH A NEW DEVICE WAS OPENED AND USED." 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 24131288 ↗
• MalfunctionJan 15, 2026Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD DOESN'T GO INSIDE THE GUIDEWIRE, IT BOUNCES OUT. SO THE MD OPENED THE NEW KIT TO FINISH THE PROCEDURE". ADDITIONAL INFORMATION RECEIVED STATES "UPON WITHDRAWAL, THE GUIDEWIRE WAS FOUND TO BE BENT". 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 24080767 ↗
• MalfunctionJan 15, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE DILATOR FAILED TO PENETRATE THE SUBCUTANEOUS ISSUE. WHEN I CHECKED WHETHER OR NOT TO USE GUIDEWIRE, IT WAS SAID TO HAVE BEEN USED, AND WHEN I TOOK IT OUT, IT WAS SAID THAT THE GUIDEWIRE WAS BENT. SO, THE MD OPENED UP THE NEW KIT TO FINISH 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 24080754 ↗
• MalfunctionJan 15, 2026Leak/Splash

  IT WAS REPORTED "THE DEVICE LEAKED WHEN CVC WAS INSERTED INTO THE PATIENT". THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080134 ↗
• MalfunctionJan 15, 2026Leak/Splash

  IT WAS REPORTED THAT "THE DEVICE LEAKED WHEN CVP WAS INSERTED INTO THE PATIENT". THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079709 ↗
• MalfunctionJan 13, 2026Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT " ON (B)(6) 2025, IN THE ANESTHESIOLOGY DEPARTMENT OF (B)(6) HOSPITAL, DURING THE INSERTION, THE DOCTOR FOUND THAT THE GUIDEWIRE COULD NOT PASS THE ARS SMOOTHLY, THE RESISTANCE WAS FOUND THEREFORE, THE CATHETER HAD TO BE REPLACED FOR REINSERTION." ADDITIONAL INFORMTION WAS RECIEVED THAT STATED "THE GUIDWIRE WAS KINKED". 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 24054284 ↗
• MalfunctionJan 13, 2026Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "(B)(6) 2025, IN THE ANESTHESIOLOGY DEPARTMENT OF BEIJING HOSPITAL, DURING THE INSERTION, THE DOCTOR FOUND THAT THE GUIDEWIRE COULD NOT PASS THE ARS SMOOTHLY, THE RESISTANCE WAS FOUND THEREFORE, THE CATHETER HAD TO BE REPLACED FOR REINSERTION." ADDITIONAL INFORMTION WAS RECIEVED THAT STATED "THE GUIDWIRE WAS KINKED". 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 24054148 ↗
• MalfunctionJan 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "THE LUER-HUB (WHITE) LEAKED AFTER IT WAS INSERTED ON THE PATIENT ON THE 16TH DAY". THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 24053968 ↗
• MalfunctionJan 7, 2026Positioning Problem

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND WIRE IS MISSING AND GETTING OUT OF JUGULAR WHILE REMOVING GUIDE WIRE (IT'S A NEW TYPE OF TRAY, AND 3 LOT OCCURRED, BUT ONLY 1 LOT WAS RECOVERED). SO, THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." ADDITIONAL INFORMATION CLARIFIED THE GUIDE WIRE WAS NOT MISSING. HOWEVER, "THE OPERATOR FELT THAT THE GUIDE WIRE WAS SLIPPING OR FREE SPINNING." THERE WAS NO PATIENT HARM OR INJURY TO THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00014, AND 3006425876-2026-00007.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989263 ↗
• MalfunctionJan 7, 2026Positioning Problem

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND WIRE IS MISSING AND GETTING OUT OF JUGULAR WHILE REMOVING GUIDE WIRE (IT'S A NEW TYPE OF TRAY, AND 3 LOT OCCURRED, BUT ONLY 1 LOT WAS RECOVERED). SO, THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." ADDITIONAL INFORMATION CLARIFIED THE GUIDE WIRE WAS NOT MISSING. HOWEVER, "THE OPERATOR FELT THAT THE GUIDE WIRE WAS SLIPPING OR FREE SPINNING." THERE WAS NO PATIENT HARM OR INJURY TO THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00014, 3006425876-2026-00015, AND 3006425876-2026-00007.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989252 ↗
• MalfunctionJan 7, 2026Positioning Problem

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND WIRE IS MISSING AND GETTING OUT OF JUGULAR WHILE REMOVING GUIDE WIRE (IT'S A NEW TYPE OF TRAY, AND 3 LOT OCCURRED, BUT ONLY 1 LOT WAS RECOVERED). SO, THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." ADDITIONAL INFORMATION CLARIFIED THE GUIDE WIRE WAS NOT MISSING. HOWEVER, "THE OPERATOR FELT THAT THE GUIDE WIRE WAS SLIPPING OR FREE SPINNING." THERE WAS NO PATIENT HARM OR INJURY TO THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989097 ↗
• MalfunctionJan 7, 2026Material Twisted/Bent

  IT WAS REPORTED THAT " THE INSERTION NEEDLES BENT (USING FOUR DIFFERENT SETS FROM THE SAME BATCH) DURING PUNCTURE OF THE RIGHT JUGULAR VEIN. THE FOURTH NEEDLE EVEN BROKE. THERE WERE NO SERIOUS COMPLICATIONS FOR THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00056, 3006425876-2026-00057, 3006425876-2026-00058, AND 3006425876-2026-00059.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988706 ↗
• MalfunctionJan 7, 2026Material Twisted/Bent

  IT WAS REPORTED THAT " THE INSERTION NEEDLES BENT (USING FOUR DIFFERENT SETS FROM THE SAME BATCH) DURING PUNCTURE OF THE RIGHT JUGULAR VEIN. THE FOURTH NEEDLE EVEN BROKE. THERE WERE NO SERIOUS COMPLICATIONS FOR THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00056, 3006425876-2026-00057, 3006425876-2026-00058, AND 3006425876-2026-00059.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988699 ↗
• MalfunctionJan 7, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "THE INSERTION NEEDLES BENT (USING FOUR DIFFERENT SETS FROM THE SAME BATCH) DURING PUNCTURE OF THE RIGHT JUGULAR VEIN. THE FOURTH NEEDLE EVEN BROKE. THERE WERE NO SERIOUS COMPLICATIONS FOR THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00056, 3006425876-2026-00057, 3006425876-2026-00058, AND 3006425876-2026-00059.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988684 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT " THE INSERTION NEEDLES BENT (USING FOUR DIFFERENT SETS FROM THE SAME BATCH) DURING PUNCTURE OF THE RIGHT JUGULAR VEIN. THE FOURTH NEEDLE EVEN BROKE. THERE WERE NO SERIOUS COMPLICATIONS FOR THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2026-00056, 3006425876-2026-00057, 3006425876-2026-00058, AND 3006425876-2026-00059.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988678 ↗
• MalfunctionJan 6, 2026Crack

  IT WAS REPORTED THAT "CRACKS WERE FOUND IN THE ARS, CAUSING BLOOD TO SEEP DURING THE INJECTION OF SALINE AND THE WITHDRAWAL OF BLOOD". 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 23973374 ↗
• MalfunctionDec 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "DURING ASPIRATION, GAS WAS CONSISTENTLY RETRIEVED, RAISING SUSPICION OF A LEAK IN THE CATHETER BODY. FOR THE SAKE OF THE PATIENT'S SAFETY, A NEW CATHETER WAS REPLACED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926176 ↗
• MalfunctionNov 24, 2025Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT "THE GUIDE WIRE IS LOOSE AND STUCK INSIDE THE CATHETER, MAKING IT IMPOSSIBLE TO REMOVE NORMALLY. IT CAN ONLY BE PULLED OUT TOGETHER WITH THE LUMEN THAT HAS BEEN INSERTED, REQUIRING A RE-INSERTION." ADDITIONAL INFORMATION RECEIVED STATES "SWG IS UNRAVELED BUT DID NOT SEPARATE. UNRAVELED SWG AND CATHETER WERE REMOVED TOGETHER." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Needle Stick/Puncture

  MAUDE report 23631617 ↗
• MalfunctionNov 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT "THE NEEDLE CANNOT THROUGH THE ARS." 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 23606219 ↗

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, Classified
  Description/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 · Terminated
  Pediatric 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 · Terminated
  Pediatric 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-1985-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
• Z-1984-2018 · Apr 11, 2018 · Terminated
  Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter and Sharps Safety Features; Product Code: ASK-24306-VC
• Z-1333-2018 · Dec 22, 2017 · Terminated
  ARROWg+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 · Terminated
  ARROWg+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 · Terminated
  ARROWg+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 · Terminated
  Arrow 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 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
• Z-1499-2009 · Feb 11, 2009 · Terminated
  Arrow ARROWg+ard CVCs (Central Venous Catheters)
• Z-0082-04 · Sep 16, 2003 · Terminated
  Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm