ARROW IPN030243Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10801902102536), received between Jun 14, 2023 and Oct 28, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (7 reports).

22 other recalls cover devices cleared under the same FDA submission (K993691); 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE PASSAGE OF THE DOUBLE LUMEN CENTRAL CATHETER, THE GUIDE WIRE BENT, CAUSING THE CATHETER ITSELF TO BENT, MAKING IT UNABLE TO CONTINUE USING THE SAME MATERIAL." THE PATIENT'S CURRENT CONDITION IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 23402097 ↗
• MalfunctionMay 9, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED "DURING THE PASSAGE OF THE CATHETER, THE TIP EXPANDED, MAKING IT IMPOSSIBLE FOR IT TO PROGRESS." 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". ASSOCIATED MDR NUMBER INCLUDES: 3006425876-2025-00379.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993729 ↗
• MalfunctionApr 14, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT "DURING THE PASSAGE OF THE CATHETER, THE TIP EXPANDED, MAKING IT IMPOSSIBLE FOR IT TO PROGRESS." A DIFFERENT CATHETER WAS 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 21832583 ↗
• MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR 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 21547994 ↗
• MalfunctionMar 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR 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 21547889 ↗
• MalfunctionMar 7, 2025Crack; Crack

  IT WAS REPORTED THAT "THE DOCTOR FOUND NEEDLE HUB CRACK 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 21547780 ↗
• MalfunctionFeb 6, 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 21321239 ↗
• MalfunctionJan 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "DURING THE REMOVAL OF THE GUIDE WIRE, IT GOT STUCK IN THE PUNCHING NEEDLE, LOSING ITS COVER WHICH SEPARATED IT FROM THE METAL CORE".

  Patient problems: Insufficient Information

  MAUDE report 21273933 ↗
• MalfunctionJan 30, 2025Crack; Crack

  IT WAS REPORTED THAT "CRACK IN THE CATHETER BODY".

  Patient problems: Insufficient Information

  MAUDE report 21273502 ↗
• MalfunctionNov 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG WAS KINKED DUE TO THE SWG SOFT 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 20696276 ↗
• MalfunctionNov 15, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT"ON (B)(6) 2024, THE DOCTOR FOUND THE SWG WAS KINKED DUE TO THE SWG SOFT 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 CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696225 ↗
• MalfunctionJun 13, 2024Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND THE SWG/ARS RESISTANCE WHEN THE SWG WAS BEING PULLED OUT OF THE ARS. THE ISSUE WAS IDENTIFIED DURING USE ON THE PATIENT." THE RETURNED SWG WAS FOUND TO BE UNRAVELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528651 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE SWG WAS FOUND KINKED DURING USE ON THE PATIENT." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS ON 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 19460525 ↗
• MalfunctionMay 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE DOCTOR FOUND THE CATHETER LEAK DURING USED ON THE PATIENT." THE DEVICE WAS REPLACED. 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 19403830 ↗
• MalfunctionMay 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT. THEY CHANGED A NEW ONE." NO PATIENT INVOLVEMENT THEREFORE NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219843 ↗
• MalfunctionNov 6, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: (B)(6) 2023, THE DOCTOR FOUND THAT THE SWG WAS KINKED PRIOR TO USE ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072540 ↗
• MalfunctionNov 6, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT: 25 SEP 2023, THE DOCTOR FOUND THAT THE SWG WAS KINKED PRIOR TO USE ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072510 ↗
• MalfunctionOct 20, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT: (B)(6) 2023, THE DOCTOR FOUND THAT THE KIT WAS NOT SEALED PROPERLY. THE ISSUE WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975046 ↗
• MalfunctionSep 7, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE PHYSICIAN FOUND THE SPRING WIRE KINKED DURING USE ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17702752 ↗
• MalfunctionJun 14, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THE DOCTOR FOUND THE KIT NOT SEALED PROPERLY PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT WITH THE DEVICE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132132 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993691. 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-1106-2021 · Jan 6, 2021 · Terminated
  Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703
• Z-0192-2020 · Jul 18, 2019 · Terminated
  Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: Th
• Z-0468-2019 · Sep 21, 2018 · Terminated
  Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter perm
• Z-0282-2019 · Aug 30, 2018 · Terminated
  Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases
• Z-2004-2018 · Apr 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions; Product Codes: ASK-4
• Z-2002-2018 · Apr 11, 2018 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42802
• Z-2003-2018 · Apr 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
• Z-2005-2018 · Apr 11, 2018 · Terminated
  ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
• Z-2001-2018 · Apr 11, 2018 · Terminated
  Double-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42802-VC and ASK-47702-VC
• Z-1335-2018 · Dec 22, 2017 · Terminated
  AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-
• Z-1152-2018 · Dec 21, 2017 · Terminated
  ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jug
• Z-0656-2018 · Oct 17, 2017 · Terminated
  ARROWg+ard Blue Plus Multi Lumen CVC (Central venous catheter); Product Code: AK-45703-ACDC; Exp. Dates Feb 2018 - Nov 2018
• Z-2332-2017 · May 9, 2017 · Terminated
  Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access
• Z-1507-2014 · Jul 17, 2013 · Terminated
  Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.

…and 7 more.