ARROW IPN030177Recalls & reported problems

Summary

The FDA's MAUDE database contains 254 adverse event reports that list this exact device (DI 00801902102362), received between Jan 27, 2021 and Nov 24, 2025 — classified as 5 injuries, 249 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (133 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 254 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, DURING OPERATION, THE SWG WAS FOUND KINKED." THE INSERTION WAS DIFFICULT. 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 23632275 ↗
• MalfunctionNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2025, DURING THE CENTRAL VENOUS CATHETERIZATION PROCEDURE, THE GUIDE WIRE INSIDE THE CENTRAL VENOUS PUNCTURE KIT WAS EASY TO KINK, WHICH SUBSEQUENTLY LED TO THE FAILURE OF THE PUNCTURE. ADDITIONALLY, THE ARS LEAK DURING USE ON THE PATIENT, WHICH AFFECTED THE OPERATION PROCESS; THE MOST SERIOUS ISSUE WAS THAT THE GUIDE WIRE WAS EXTREMELY EASY TO KINK, AND THIS WAS THE KEY CAUSE OF THE PUNCTURE FAILURE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES "THE DOCTOR THINKS OUR SWG IS EASY TO KINK". MULTIPLE PUNCTURE KITS WERE REPLACED, CAUSING UNNECCESSARY LOST AND INJURY TO THE PATIENT. ASSOCIATED MDR NUMBER INCLUDES: 3006425876-2025-01100, 3006425876-2025-01099.

  Patient problems: Insufficient Information

  MAUDE report 23623806 ↗
• MalfunctionNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2025, DURING THE CENTRAL VENOUS CATHETERIZATION PROCEDURE, THE GUIDE WIRE INSIDE THE CENTRAL VENOUS PUNCTURE KIT WAS EASY TO KINK, WHICH SUBSEQUENTLY LED TO THE FAILURE OF THE PUNCTURE. ADDITIONALLY, THE ARS LEAK DURING USE ON THE PATIENT, WHICH AFFECTED THE OPERATION PROCESS; THE MOST SERIOUS ISSUE WAS THAT THE GUIDE WIRE WAS EXTREMELY EASY TO KINK, AND THIS WAS THE KEY CAUSE OF THE PUNCTURE FAILURE. ASSOCIATED MDR NUMBER INCLUDES: 3006425876-2025-01100, 3006425876-2025-01099, AND 3006425876-2025-01136.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622255 ↗
• MalfunctionNov 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT"ON (B)(6) 2025, DURING THE CENTRAL VENOUS CATHETERIZATION PROCEDURE, THE GUIDE WIRE INSIDE THE CENTRAL VENOUS PUNCTURE KIT WAS EASY TO KINK, WHICH SUBSEQUENTLY LED TO THE FAILURE OF THE PUNCTURE. ADDITIONALLY, THE ARS LEAK DURING USE ON THE PATIENT, WHICH AFFECTED THE OPERATION PROCESS; THE MOST SERIOUS ISSUE WAS THAT THE GUIDE WIRE WAS EXTREMELY EASY TO KINK, AND THIS WAS THE KEY CAUSE OF THE PUNCTURE FAILURE. ASSOCIATED MDR NUMBER INCLUDES: 3006425876-2025-01100, 3006425876-2025-01099, AND 3006425876-2025-01136.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622254 ↗
• MalfunctionNov 19, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2025, DURING THE INSERTION, THE SWG COULD NOT ENTER AT ABOUT 12CM. WHEN THE GUIDE WIRE WAS WITHDRAWN, IT WAS FOUND THAT THE GUIDE WIRE WAS BENT. REPLACE IT WITH A NEW ONE AND ENTER SUCCESSFULLY." 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 23597452 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE KINKING". AS A RESULT, A NEW CATHETER WAS INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23597378 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE KINKING". AS A RESULT, A NEW CATHETER WAS INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597044 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE GUIDE WIRE KINKING". AS A RESULT, A NEW CATHETER WAS INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597026 ↗
• MalfunctionNov 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE INSERTION, THE DOCTOR FOUND THE RESISTANCE, AND THEN THE SWG WAS FOUND KINKED AND CAN'T USE IT. THEY CHANGED A NEW ONE. 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 23596890 ↗
• MalfunctionNov 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND SWG KINKED PRIOR TO 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 23582409 ↗
• MalfunctionNov 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025,15:41 THE DOCTOR PERFORMED CENTRAL VENOUS CATHETERIZATION ON THE PATIENT, THE DOCTOR FOUND THE SWG WAS KINKED DURING INSERTION." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQURIED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582321 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "(B)(6) 2025, THE ARS WAS FOUND 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 23582309 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT" (B)(6) 2025, THE ARS WAS FOUND LEAK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM RO INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582280 ↗
• MalfunctionNov 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT" (B)(6) 2025, THE ARS WAS FOUND LEAK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW SET TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM RO INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582243 ↗
• MalfunctionNov 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT "(B)(6) 2025, DOCTOR FOUND THE DILATOR TIP DAMAGED 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 23532825 ↗
• MalfunctionNov 11, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT"26 SEP 2025, THE RESISTANCE WAS FOUND WHEN DILATOR WAS INSERTED INTO AND IT CAN'T ADVANCED, AND THEN THE SWG WAS REMOVED, THE SWG WAS FOUND KINKED. AND 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 23523129 ↗
• MalfunctionNov 11, 2025Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, THE RESISTANCE WAS FOUND WHEN DILATOR WAS INSERTED INTO AND IT CAN'T ADVANCED, AND THEN THE SWG WAS REMOVED, THE SWG WAS FOUND KINKED. AND 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 23523114 ↗
• MalfunctionNov 11, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "(B)(6) 2025, THE RESISTANCE WAS FOUND WHEN DILATOR WAS INSERTED INTO AND IT CAN'T ADVANCED, AND THEN THE SWG WAS REMOVED, THE SWG WAS FOUND KINKED. AND 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 23523102 ↗
• MalfunctionNov 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT"(B)(6) 2025, AFFILIATED HOSPITAL OF (B)(6), IN ICU, THE DOCTOR FOUND CATHETER LEAK DURING USED ON THE PATIENT." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CLARIFIED THE ARS SYRINGE WAS LEAKING. 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 23477067 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR PERFORMED DEEP VEIN PUNCTURE AND CATHETERIZATION FOR THE PATIENT. BEFORE CATHETERIZATION, WHEN CHECKING THE PERFORMANCE OF THE CATHETER, THE DOCTOR FOUND THAT THE GUIDE WIRE WAS BROKEN AND DISPLACED AT THE BEND, SO THE PUNCTURE COULD NOT BE CARRIED OUT, SO HE COULD ONLY REPLACE A NEW CATHETER FOR PUNCTURE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23476907 ↗
• MalfunctionNov 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "(B)(6) 2025, IT WAS DIFFICULT TO INSERT THE CATHETER. AFTER PULLING OUT, IT WAS FOUND THAT THE GUIDE WIRE WAS KINKED TO 90 DEGREES, SO THE PATIENT WAS GIVEN A KNIFE TO GUIDE THE CATHETER THROUGH THE GUIDE WIRE AFTER THE SKIN WAS BROKEN. THIS EVENT DID NOT CAUSE HARM TO THE PATIENT." 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 23476856 ↗
• MalfunctionNov 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "ON (B)(6) 2025, THE DOCTOR INDWELLING THE FEMORAL VEIN DEEP VENOUS CATHETER UNDER THE GUIDANCE OF B-ULTRASOUND. WHEN INSERTING THE GUIDE WIRE AFTER NORMAL PUNCTURE AND SKIN EXPANSION, HE FOUND THAT THE GUIDE WIRE WAS FOUND KINKED, AND THE CATHETER COULD NOT BE SUCCESSFULLY GUIDED INTO THE BLOOD VESSEL. AFTER RE UNPACKING A NEW SET OF VENOUS CATHETER PACKAGE, THE CATHETER WAS SUCCESSFULLY PLACED AFTER USING THE NEW GUIDE WIRE, AND THE PATIENT HAD NO OTHER INJURY IN THE PROCESS." 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 23468185 ↗
• MalfunctionOct 20, 2025Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, (B)(6) ENCOUNTERED AN ISSUE WITH THE GUIDEWIRE WHEN USING OUR CENTRAL VENOUS CATHETER. THE GUIDEWIRE WAS FOUND KINKED AND COULD NOT BE INSERTED NORMALLY. AFTER REPLACEMENT, THE RELEVANT ISSUE WAS RESOLVED." 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 23334789 ↗
• MalfunctionOct 20, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "DURING INSERTION, THE SWG WAS FOUND EASY TO KINK, THE RESISTANCE WAS FOUND WHEN THE SWG INSERTED INTO ARS. " 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 23334770 ↗
• MalfunctionOct 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, THE DOCTOR FOUND SWG KINKED DURING INSERTION." 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 23334729 ↗

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-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-1985-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) Central Venous Catheterization Kit; Product Code: ASK-24306-WHC1 and ASK-24306-WHC2
• 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