ARROW IPN030887Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801902000606), received between Mar 5, 2021 and Dec 2, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 reports).

24 other recalls cover devices cleared under the same FDA submission (K862056); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Difficult to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Difficult to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "DURING THE CATHETER INSERTION PROCEDURE, A PROBLEM WAS IDENTIFIED WITH THE GUIDE WIRE: DIFFICULTY IN ADVANCING THE WIRE, BENDING OF THE GUIDE, EXCESSIVE RESISTANCE WHEN TRYING TO INSERT IT. ON THE SECOND ATTEMPT, THE MATERIAL FROM THE SAME BATCH ALSO HAD THE SAME PROBLEM." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-01157.

  Patient problems: Insufficient Information

  MAUDE report 20825203 ↗
• MalfunctionDec 2, 2024Difficult to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Difficult to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "DURING THE CATHETER INSERTION PROCEDURE, A PROBLEM WAS IDENTIFIED WITH THE GUIDE WIRE: DIFFICULTY IN ADVANCING THE WIRE, BENDING OF THE GUIDE, EXCESSIVE RESISTANCE WHEN TRYING TO INSERT IT. ON THE SECOND ATTEMPT, THE MATERIAL FROM THE SAME BATCH ALSO HAD THE SAME PROBLEM." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2024-01155.

  Patient problems: Insufficient Information

  MAUDE report 20825188 ↗
• MalfunctionOct 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "TRIPLE LUMEN CENTRAL VENOUS CATHETER, THE BLUE PATHWAY WAS FOUND TO BE OBSTRUCTED. A TEST WITH METHYLENE BLUE CONFIRMED THIS. OTHER PATHWAYS WERE NORMAL." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED BY THE CUSTOMER AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20351378 ↗
• MalfunctionOct 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "TRIPLE LUMEN CENTRAL VENOUS CATHETER, 20 CM WITH ONE OF THE PATHWAYS OBSTRUCTED (BLUE PATHWAY), NOTICED AFTER PASSING THE CATHETER. THE OTHER PATHWAYS FUNCTIONED NORMALLY." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED BY THE CUSTOMER AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20351318 ↗
• MalfunctionFeb 15, 2024Unraveled Material; Material Deformation; Physical Resistance/Sticking; Unraveled Material; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED "SURGEON FOUND THAT THE GUIDEWIRE DEFORMATION WHEN HE REMOVED THE GUIDEWIRE FROM PATIENT, SO HE MUST OPEN NEW CVC SET FOR REPLACEMENT AND SOLVING THIS ISSUED." NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710358 ↗
• MalfunctionDec 12, 2023Gas/Air Leak; Incomplete or Inadequate Connection; Gas/Air Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT: THEY EXPERIENCED THAT ARS IS NOT "SEALED" PROPERLY AT THE CONNECTION OF NEEDLE AND SYRINGE AND THAT ARS SUCKS IN THE AIR WHEN USED. THE ISSUE WAS IDENTIFIED DURING USE BUT THERE WAS NO REPORTED PATIENT HARM OR INTERVENTION NEEDED. ASSOCIATED COMPLAINTS 3006425876-2023-01227, 3006425876-2023-01229 AND 3006425876-2023-01230.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309255 ↗
• MalfunctionApr 16, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: "EXTENSION LINE/LUER HUB SEPARATION". THE CATHETER WAS REMOVED AND A PICC LINE WAS PLACED. IT WAS REPORTED THERE WAS NO CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679723 ↗
• MalfunctionMar 5, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: CATHETER PLACED FOR PATIENT TO UNDERGO TRANSPLANT AND AFTER 22 DAYS THE CATHETER WAS REMOVED "DUE TO PILLOW WAS WET". THE CATHETER BROKE AT THE BROWN CONNECTION. A SECOND CATHETER WAS PLACED IN THE OPERATING ROOM AND 10 DAYS AFTER IT WAS REMOVED BECAUSE "IT HAD THE SAME FAULT". THE PATIENT'S MOTHER REFUSED ANOTHER CATHETER AND A PICC LINE WAS PLACED. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424837 ↗
• MalfunctionMar 5, 2021Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: CATHETER PLACED FOR PATIENT TO UNDERGO TRANSPLANT AND AFTER 22 DAYS THE CATHETER WAS REMOVED "DUE TO PILLOW WAS WET". THE CATHETER BROKE AT THE BROWN CONNECTION. A SECOND CATHETER WAS PLACED IN THE OPERATING ROOM AND 10 DAYS AFTER IT WAS REMOVED BECAUSE "IT HAD THE SAME FAULT". THE PATIENT'S MOTHER REFUSED ANOTHER CATHETER AND A PICC LINE WAS PLACED. THE PATIENT WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424515 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K862056. One submission often covers many models, so check the product and lot details in each record.

• Z-2377-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP ACCESS TRAY/ASK-04001-MS RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1 VESSE
• Z-1118-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
• Z-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• Z-0723-2019 · Nov 14, 2018 · Terminated
  Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide sho
• Z-2818-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous cathe
• Z-2819-2018 · Jul 10, 2018 · Terminated
  HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous cath
• Z-2336-2018 · May 11, 2018 · Terminated
  Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single
• Z-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• Z-1978-2018 · Apr 11, 2018 · Terminated
  Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features; Product Code: ASK-15402-HOP
• Z-1982-2018 · Apr 11, 2018 · Terminated
  ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
• Z-1332-2018 · Dec 22, 2017 · Terminated
  (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12
• Z-0654-2018 · Oct 17, 2017 · Terminated
  Arrow Multi Lumen CVC Kit (Central venous catheter); Product Code: CDC-15703-1A; Exp. Dates Feb 2018 - Nov 2018
• Z-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
• Z-0652-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dat
• Z-0648-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.