ARROW IPN030141Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00801902102287), received between Aug 11, 2023 and Dec 16, 2025 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT " THE GUIDE WIRE KINKING". THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817314 ↗
• MalfunctionSep 4, 2025Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED "A CVC WAS TO BE PLACED. AFTER THE NURSE PREPARED THE NECESSARY MATERIALS, THE PHYSICIAN PERFORMED THE CVC INSERTION UNDER FULL STERILE CONDITIONS AND PROTECTIVE EQUIPMENT. THE INSERTION PROCEDURE WENT SMOOTHLY. HOWEVER, WHEN INSERTING THE GUIDEWIRE, DIFFICULTY WAS ENCOUNTERED. UPON REMOVAL, THE GUIDEWIRE WAS FOUND TO BE DEFORMED." ANOTHER GUIDEWIRE WAS USED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965169 ↗
• MalfunctionJul 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "GUIDEWIRE IS BENT." THE DEVICE WAS REPLACED. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588588 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PLACED ON 6/5, WAS USED NORMALLY FOR IVD UNTIL THE NIGHT SHIFT ON 6/10 WHEN CONTINUOUS DRIPPING AND WETTING NEAR THE MARK II AREA OF THE CVC TUBING WAS FOUND. THE DOCTOR REMOVED IT AND TESTED IT, AND INJECTION FLUID SPRAYED OUT FROM ABOUT 19 CM FROM THE BROWN END". THE USER CHANGED TO A NEW CATHETER. 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 22436388 ↗
• MalfunctionJun 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "INTRODUCER NEEDLE BENT". THERE WAS NO PATIENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22299382 ↗
• MalfunctionMay 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "IT WAS FOUND THAT THE DILATOR TOO SOFT AND BECOMING SPLIT (BIFURCATED)". THE USER CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995420 ↗
• MalfunctionApr 23, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "THE LUER-HUB(BROWEN) BROKEN." ADDITIONAL INFORMATION RECEIVED REPORTS "WHEN THE NURSE WAS TURNING THE PATIENT OVER, FOUND THAT THE LUER-HUB (BROWN)HAD BROKEN AND FALLEN OFF, SO CLAMPED IT WITH A KELLY HEMOSTATIC FORCEPS." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889365 ↗
• MalfunctionApr 9, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "THE CATHETER OR GUIDE WIRE WAS DAMAGED, CAUSING TUBE BLOCKAGE." THE DEVICE WAS REMOVED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS CANNOT BE PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21807859 ↗
• MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE SWG FRONT 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 21548529 ↗
• MalfunctionJan 31, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE NEEDLE IS SUSPECTED OF HAVING A BLOCKAGE". ANOTHER SET WAS OPENED TO RESOLVE THE ISSUE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282586 ↗
• MalfunctionJan 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "THE PHYSICIAN REPORTED ARS DAMAGE AT THE CONNECTOR, RENDERING IT UNUSABLE. CONSEQUENTLY, ANOTHER SET WAS OPENED, AND THE CVC WAS SUCCESSFULLY INSERTED WITHOUT ANY SAFETY CONCERNS FOR THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191319 ↗
• MalfunctionDec 10, 2024Dent in Material; Dent in Material

  IT WAS REPORTED, "PRESENCE OF DENTS, MAKING IT PRONE TO BREAKAGE." 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 20895631 ↗
• MalfunctionDec 10, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED "UNABLE TO FILL WITH WATER." 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 20895543 ↗
• MalfunctionDec 10, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED "UNABLE TO FILL WITH WATER." 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 20895038 ↗
• MalfunctionSep 27, 2024Crack; Crack

  IT WAS REPORTED THAT "THE WHITE LUER-HUB WAS BROKEN WHEN IT WAS UNSCREWED. THE CATHETER REMAINED IN PLACE FOR A TOTAL OF 4 DAYS BEFORE THE BREAKAGE OCCURRED. THE LEUR HUB WAS CRACKED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20320700 ↗
• MalfunctionSep 24, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED "THE SWG RESISTANCE WHEN IT PLACING PROCESS." ADDITIONAL INFORMATION REPORTS, "WHEN THE INTRAVENOUS CATHETER WAS BEING PLACED, THE INSIDE THE GUIDEWIRE BROKE. THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294733 ↗
• MalfunctionSep 20, 2024Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED THAT: "THE PUNCTURE NEEDLE INSIDE THE PACKAGING WAS BLUNTED, MAKING IT IMPOSSIBLE TO SUCCESSFULLY PUNCTURE THE PATIENT." RETURNED NEEDLE WAS FOUND TO BE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20265670 ↗
• MalfunctionAug 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "(B)(6) 2024, THE CATHETER WAS FOUND TO BE LEAKING DURING USE ON THE PATIENT. INVOLVED 1 PC."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062778 ↗
• MalfunctionAug 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "THERE WAS A LEAK AT THE JUNCTION OF THE HUB AND CATHETER. THERE WAS NO HARM TO THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19979508 ↗
• MalfunctionJun 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "CVC REMOVED DUE TO ITS LEAKING. PROXIMAL LINE BREAKAGE/LEAKAGE." THE USER CHANGED TO A NEW SET. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444813 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED "LUMEN BREAKAGE". NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. NO DELAY TO THERAPY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFOMATION HAS BEEN REQUESTED, FURTHER DETAILS UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19069286 ↗
• MalfunctionApr 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "DILATOR DAMAGED DURING INSERTION, IT WAS FOUND THAT THE DILATOR WAS DEFORMED AND THE SWG COULD NOT BE ENTERED SMOOTHLY." THEY CHANGED TO A NEW SET. 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 19061281 ↗
• MalfunctionMar 26, 2024Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow

  IT WAS REPORTED THAT " THE PHYSICIAN PERFORMED THE PROCEDURE, HE FOUND A SYRINGE LEAKAGE, IT SUSPECTED THAT THERE WAS AN IMPURITY AND CAUSING IT TO BE BLOCKED/OCCLUDED. NO PATIENT HARM." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978541 ↗
• MalfunctionMar 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ""THE CATHETER WAS BROKEN, LEADING TO BLOOD AND WATER LEAKAGE". THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT HARM OR INJURY. THERE WAS NO DELAY TO THERAPY. THE CURRENT STATUS OF THE PATIENT IS "UNKNOWN".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18865267 ↗
• MalfunctionFeb 26, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT "OPEN THE PACKAGE, THE EMPTY NEEDLE CONNECTOR WAS LOOSE AND CANNOT BE USED." THE PATIENT WAS REPORTED AS FINE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE RETURNED DEVICE SHOWED THAT THE ISSUE WAS A CRACK IN THE NEEDLE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775798 ↗

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