ARROW IPN030129Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00801902102225), received between Jan 27, 2021 and Nov 20, 2025 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (25 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 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Crack; Crack

  IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND THE NEEDLE HUB HAS CRACK 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 23606153 ↗
• MalfunctionNov 18, 2025Difficult or Delayed Positioning; Material Twisted/Bent; Difficult or Delayed Positioning; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2025, WHEN THE SUBCLAVIAN DEEP VEIN CATHETERIZATION WAS PERFORMED, THE BLOOD RETURN WAS SMOOTH, THE SWG PLACEMENT WAS NOT SMOOTH FOR THREE TIMES, AND IT WAS CHANGED TO A NEW ONE AND SUCCESSFULLY." THE SWG WAS FOUND KINKED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582508 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "ON (B)(6) 2025 THE PATIENT UNDERWENT PARACENTESIS AND CATHETERIZATION DUE TO ASCITES, AND FLUID LEAKAGE OCCURRED FROM THE PUNCTURE POINT THE NEXT DAY AFTER SURGERY. AFTER THAT, THE DOCTOR TOOK THE OPERATION OF EXTUBATION AND RE CATHETERIZATION." 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 23377167 ↗
• MalfunctionOct 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "(B)(6) 2025, THE PATIENT UNDERWENT PARACENTESIS AND CATHETERIZATION DUE TO ASCITES, AND FLUID LEAKAGE OCCURRED FROM THE PUNCTURE POINT THE NEXT DAY AFTER SURGERY. " THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. HERE 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 23377162 ↗
• MalfunctionOct 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2025, ANESTHESIOLOGY DEPARTMENT, (B)(6) HOSPITAL THE DOCTOR FEEDBACK WHEN REMOVE THE SWG, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 23259953 ↗
• MalfunctionSep 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND A SIGNIFICANT AMOUNT OF GAS CAN STILL BE ASPIRATED 2 CM BELOW THE SKIN SURFACE, SUGGESTING THE NEEDLE IS UNABLE TO MAINTAIN NEGATIVE PRESSURE." THE USER CHANGED TO A NEW SET TO RESOVLE 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 23132813 ↗
• MalfunctionSep 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "(B)(6) 2025, WHEN MEASURING CENTRAL VENOUS PRESSURE FOR PATIENTS, THE DOCTOR FOUND THE LEAK BETWEEN THE CATHETER AND JUNCTURE HUB 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 23094845 ↗
• MalfunctionJun 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "ON (B)(6) 2025, AT 11:10 A.M., DURING INSERTION, THE DOCTOR FOUND THAT THE ARS WAS NOT SEALING WELL, AND THERE WAS GAS IN THE RETRACTIONS, SO HE IMMEDIATELY GAVE A REPLACEMENT CENTRAL VENOUS CATHETER AND THEN PERFORMED CENTRAL VENOUS PUNCTURE AGAIN." 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 22307685 ↗
• MalfunctionJun 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " ON (B)(6) 2025, THE DOCTOR FOUND THE SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22297465 ↗
• MalfunctionMay 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, "ON (B)(6) 2024, DURING INSERTION, THE DOCTOR FOUND SWG KINKED, THE SWG CAN'T BE INSERTED INTO SO THEY CHANGED A NEW ONE." 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 22095824 ↗
• MalfunctionMay 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "(B)(6) 2025, EMERGENCY RESUSCITATION ROOM REPORTING, THE NURSE FOUND THE SWG KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018523 ↗
• MalfunctionApr 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, DURING THE INSERTION, THE GUIDEWIRE WAS INSERTED SMOOTHLY, BUT DURING THE USE OF THE DILATOR, THE DILATOR WAS BENT, WHICH PREVENTED FURTHER OPERATION, AND THE DILATOR WAS PULLED OUT AND FOUND THE DILATOR BENT, AND THEN REPLACED WITH A NEW DILATOR, WHICH WAS INSERTED SMOOTHLY." 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 21890418 ↗
• MalfunctionApr 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ON (B)(6) 2025, THE DOCTOR FOUND THE ARS LEAK 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 21824791 ↗
• MalfunctionMar 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND A LEAK BETWEEN THE CATHETER AND JUNCTURE HUB DURING USED ON 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 21731658 ↗
• MalfunctionMar 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "ON THE SIXTH DAY OF THE CATHETER, THE DOCTOR FOUND THE EXTENSION LINE AND LUER HUB SEPARATED DURING USED ON 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 21719071 ↗
• MalfunctionFeb 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR FOUND SWG KINKED DURING USED ON 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 21456477 ↗
• MalfunctionJan 31, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR FOUND SWG KINKED DURING INSERTION USED ON 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 21282566 ↗
• MalfunctionJan 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE CATHETER RUPTURED DURING USED ON 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 21178294 ↗
• MalfunctionJan 16, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE NURSE FOUND THE SWG KINKED DURING USED ON 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 21167647 ↗
• MalfunctionJan 13, 2025Crack; Crack

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE LUER HUB/FITTING HAS CRACK DURING USED ON 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 21137043 ↗
• MalfunctionJan 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE ARS LEAK DURING USED ON 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 21067901 ↗
• MalfunctionDec 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE CATHETER LEAK DURING USE ON THE PATIENT. THEY CHANGED TO A NEW ONE TO RESOLVE THE ISSUE. NO HARM FOR THE PATIENT. THE PATIENT'S CONDITION IS FINE. NO MEDICAL INTERVENTION WAS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865466 ↗
• MalfunctionNov 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED: "THE PHYSICIAN FOUND THAT THE SWG WAS KINKED DURING USE ON THE PATIENT." THE OPERATOR CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685264 ↗
• MalfunctionNov 13, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2024, THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT." THE OPERATOR CHANGED TO A NEW SET. 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 20675094 ↗
• MalfunctionSep 27, 2024Material Twisted/Bent; Material Too Soft/Flexible; Material Twisted/Bent; Material Too Soft/Flexible

  IT WAS REPORTED "ON (B)(6) 2024,THE SWG IS SOFT, IT CANNOT BE USED TOGETHER WITH THE DILATOR WHEN USED ON THE PATIENT. NO HARM FOR THE PATIENT." ADDITIONAL INFORMATION REPORTS "THE SWG IS EASY TO KINK." THE USER CHANGED TO A NEW SET. 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 20322202 ↗

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