ARROW IPN030150Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801902102300), received between Apr 14, 2021 and Dec 3, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "ON REMOVAL OF A VASCATH WIRE BY A DR, THE WIRE UNRAVELED. NO OBVIOUS WIRE PIECE LEFT INSITU." 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 23706097 ↗
• MalfunctionNov 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "GUIDEWIRE UNCOILS AT TWO BREAKPOINTS, COMPONENTS COME APART. GUIDEWIRE HOOKS ON NEEDLE BEVEL THAT IS PROXIMAL IN BLOOD VESSEL". AS A RESULT, A NEW DEVICE WAS USED. NO PATIENT HARM OR INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23597223 ↗
• MalfunctionAug 27, 2025Material Separation; Material Separation

  IT WAS REPORTED "WHEN THE GUIDEWIRE IS PULLED OUT, THE OUTER FULL STEEL WIRE SEPARATES FROM THE CENTRAL STEEL WIRE, WHICH MAY CAUSE VASCULAR INJURY." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS COULD NOT BE PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00774, 3006425876-2025-00801, AND 3006425876-2025-00800.

  Patient problems: Insufficient Information

  MAUDE report 22902522 ↗
• MalfunctionAug 27, 2025Material Separation; Material Separation

  IT WAS REPORTED "WHEN THE GUIDEWIRE IS PULLED OUT, THE OUTER FULL STEEL WIRE SEPARATES FROM THE CENTRAL STEEL WIRE, WHICH MAY CAUSE VASCULAR INJURY." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS COULD NOT BE PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00774, 3006425876-2025-00802, AND 3006425876-2025-00800.

  Patient problems: Insufficient Information

  MAUDE report 22902502 ↗
• MalfunctionAug 27, 2025Material Separation; Material Separation

  IT WAS REPORTED "WHEN THE GUIDEWIRE IS PULLED OUT, THE OUTER FULL STEEL WIRE SEPARATES FROM THE CENTRAL STEEL WIRE, WHICH MAY CAUSE VASCULAR INJURY.". ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS COULD NOT BE PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00774, 3006425876-2025-00802, 3006425876-2025-00801, AND 3006425876-2025-00800.

  Patient problems: Insufficient Information

  MAUDE report 22902494 ↗
• MalfunctionAug 27, 2025Material Separation; Material Separation

  IT WAS REPORTED "WHEN THE GUIDEWIRE IS PULLED OUT, THE OUTER FULL STEEL WIRE SEPARATES FROM THE CENTRAL STEEL WIRE, WHICH MAY CAUSE VASCULAR INJURY." THE USER CHANGED TO A NEW SET. THERE WAS NO PATIENT COMPLICATIONS. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00774, 3006425876-2025-00802, 3006425876-2025-00801, AND 3006425876-2025-00800.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902408 ↗
• MalfunctionJul 14, 2025Crack; Crack

  IT WAS REPORTED "IN THE UNIT AS THE DOCTOR WAS INSERTING THE CVC DISCOVERED THAT THE NEEDLE HAD A HUB CRACK AS HE WAS NOT ABLE TO AS PIRATE THE BLOOD." THE DEVICE WAS REMOVED AND REPLACED. 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 22494398 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED "WHEN ATTEMPTING TO SEPARATE THE INFUSION END AND INFUSION SLEEVE OF THE TRIPLE-LUMEN CATHETER, THE TUBING BROKE, MAKING THE TUBING UNUSABLE. ADDITIONALLY, THE TUBING'S SEAL NEEDS TO BE REINFORCED TO PREVENT BLOOD LOSS FROM THE PATIENT THROUGH THE BROKEN TUBING." 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 22437476 ↗
• MalfunctionMar 13, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT: "THE GUIDE WIRE BIFURCATION.". A NEW SET WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593639 ↗
• MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "SWG BENT. PRIOR TO USE ON PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609748 ↗
• MalfunctionOct 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "THE WIRE SPLIT INTO TWO SEPARATE PARTS". ADDITIONAL INFORMATION CLARIFIED THE SEPARATION WAS FOUND WHEN THE USER UNPACKED THE PRODUCT. THEY HAD NOT USED THE DEVICE YET. SUBSEQUENTLY, 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 20472675 ↗
• MalfunctionSep 27, 2024Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED "THE WIRE COULD NOT THROUGH THE ARS". ADDITIONAL INFORMATION REPORTS THE GUIDWIRE WAS KINKED. THE DEVICE WAS REMOVED AND REPLACED. 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 20321442 ↗
• MalfunctionJun 2, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SWG KINKED". THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444857 ↗
• MalfunctionOct 31, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT: SWG RESISTANCE/KINKING. THE ISSUE WAS IDENTIFIED DURING USE ON A PATIENT BUT THERE WERE NO ADVERSE REACTIONS REPORTED. THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037597 ↗
• MalfunctionFeb 7, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "WHEN INTRODUCING THE GUIDEWIRE, THE GUIDEWIRE LOOKED SPLIT." THE INSERTION SITE WAS THE RIGHT FEMORAL. THE DEVICE WAS REPLACED AND ANOTHER ATTEMPT WAS SUCCESSFUL. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311586 ↗
• MalfunctionApr 14, 2021Unraveled Material; Unraveled Material

  DURING CATHETER INSERTION, THE GUIDEWIRE UNRAVELED. A SECOND DEVICE WAS USED AND THE SAME ISSUE OCCURRED. A THIRD DEVICE WAS SUCCESSFULLY PLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668870 ↗
• MalfunctionApr 14, 2021Unraveled Material; Unraveled Material

  DURING CATHETER INSERTION, THE GUIDEWIRE UNRAVELED. A SECOND DEVICE WAS USED AND THE SAME ISSUE OCCURRED. A THIRD DEVICE WAS SUCESSFULLY PLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668866 ↗

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