ARROW IPN033091Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 30801931122981), received between Jun 21, 2023 and Jan 6, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "SWG FOLDED". THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973384 ↗
• MalfunctionSep 23, 2025Material Frayed; Material Frayed

  IT WAS REPORTED "AN ANESTHESIOLOGIST AT MONTE SINAI HOSPITAL, ATTEMPTED CENTRAL VENOUS CATHETER PLACEMENT, BUT THE GUIDEWIRE UNRAVELED IN ALL CATHETERS." THE NEEDLE AND GUIDEWIRE WAS REMOVED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00788, AND 9680794-2025-00769.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23122791 ↗
• MalfunctionSep 23, 2025Material Frayed; Material Frayed

  IT WAS REPORTED "AN ANESTHESIOLOGIST AT MONTE SINAI HOSPITAL, ATTEMPTED CENTRAL VENOUS CATHETER PLACEMENT, BUT THE GUIDEWIRE UNRAVELED IN ALL CATHETERS." THE NEEDLE AND GUIDEWIRE WAS REMOVED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2025-00788, 9680794-2025-00787, AND 9680794-2025-00769.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23122772 ↗
• MalfunctionJul 15, 2025Fluid/Blood Leak; Migration; Fluid/Blood Leak; Migration

  IT WAS REPORTED THAT "THE PATIENT IS IRRITABLE. THE PSYCHOLOGY STAFF NOTES THAT THE PATIENT HAS BLEEDING IN THE NECK, SO THEY EXAMINE HIM AND NOTICE THAT THE CENTRAL VENOUS CATHETER IS OUT OF PLACE. THEREFORE, PRESSURE IS APPLIED TO THE INSERTION SITE, STITCHES AND A TRANSPARENT DRESSING ARE REMOVED, ASEPSIS IS PERFORMED AND STERILE GAUZE IS PLACED, AND THE DOCTOR ON DUTY IS NOTIFIED AND THE PATIENT IS GIVEN A PERIPHERAL LINE." THERE WAS NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22506340 ↗
• MalfunctionJun 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "GUIDEWIRE NOTICED AS KINKED. DIFFICULT TO USE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 22202709 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED "FRACTURED DISTAL LUMEN". THE CATHETER WAS REMOVED. 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 22018297 ↗
• InjuryMay 2, 2025Material Separation; Material Separation

  IT WAS REPORTED "A NEEDLE WAS PLACED INTO THE INTERNAL JUGULAR VEIN. THE WIRE WAS THEN ADVANCED THROUGH THE NEEDLE. THERE WAS RESISTANCE TO ADVANCEMENT OF THE WIRE. ON RETRACTION OF THE WIRE, THERE WAS RESISTANCE AND WHEN THE WIRE EXITED THE NEEDLE, THE OUTER LAYER OF THE WIRE APPEARED TO HAVE COME UNDONE. THE JUGULAR VEIN WAS EXAMINED UNDER ULTRASOUND AND A FRAGMENT OF WIRE APPEARED TO BE LODGED IN THE JUGULAR VEIN. THE CHILD WAS TAKEN TO THE CATH LAB AND THE TIP OF THE WIRE WAS RETRIEVED UNDER RADIOLOGICAL GUIDANCE. THE FRAGMENT IS SHOWN BELOW. IT APPEARED TO CONSIST OF A SMALL PART OF THE CENTRAL CORE WIRE ATTACHED TO A LONGER PART OF THE OUTER WIRE." THE PATIENT HAS RECOVERED UNEVENTFULLY WITH NO OTHER CONSEQUENCES.

  Patient problems: Foreign Body In Patient

  MAUDE report 21950058 ↗
• MalfunctionApr 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2025, (B)(6) HOSPITAL, ANAESTHESIA DEPARTMENT BEFORE USING THE PRODUCT, THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21825770 ↗
• MalfunctionJan 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "AFTER 17 DAYS OF USE, LEAKAGE WAS OBSERVED AT THE INJECTION SITES WHEN ADMINISTERING MEDICATION THROUGH BOTH THE BLUE AND WHITE INJECTION PORTS". A NEW SET WAS OPENED TO RESOLVE THE ISSUE. THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148181 ↗
• MalfunctionDec 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THERE HAVE BEEN DIFFICULTIES WITH THE INSERTION OF THE DILATOR FOR THE CENTRAL VENOUS PRESSURE (CVP) CATHETER DUE TO BIFURCATION AT THE DISTAL END". A NEW SET WAS USED TO COMPLETE THE PROCEDURE. THE CONDITION OF THE PATIENT IS REPORTED TO BE 'FINE'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20978200 ↗
• MalfunctionMay 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WHEN CHECKING THE LINES OF A CENTRAL CATHETER BY INJECTING NACL WE DETECTED A LEAK ON ONE OF THE 3 LINES AT THE LEVEL OF THE JUNCTION BETWEEN THE JUNCTION HUB AND THE SKIN. AFTER CHECKING, IT TURNED OUT THAT ONLY THIS LINE HAD THIS PROBLEM. A NEW CATHETER WAS INSERTED WITH CONSEQUENCE THAT THE PATIENT WAS SEDATED WHEN INSERTION OF THE OTHER CATHETER." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 19268208 ↗
• MalfunctionMay 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "WHEN ADVANCING THE GUIDE, THEY NOTIFY THAT IT DEFORMS EASILY." 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 19249341 ↗
• MalfunctionMay 6, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "WHEN ADVANCING THE GUIDE, THEY NOTIFY THAT IT DEFORMS EASILY." 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 19248261 ↗
• MalfunctionDec 5, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT"09 NOV 2023, THE CATHETER WAS FOUND TO BE LEAKING DURING USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18265498 ↗
• MalfunctionNov 28, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT " THE GUIDEWIRE WAS FOUND KINKED AFTER OPENING THE PACKAGE." PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18215261 ↗
• MalfunctionSep 26, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THE SPRING WIRE GUIDE WAS FOUND KINKED WHEN OPENING THE PACKAGE. A NEW KIT WAS OBTAINED FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817691 ↗
• MalfunctionAug 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE EXTENSION LINE WAS FOUND LEAKING DURING USE ON THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17645605 ↗
• InjuryAug 22, 2023Material Separation; Material Separation

  THE COMPLAINT IS REPORTED AS: "ON (B)(6) 2023 DURING THE PROCEEDINGS OF ULTRASOUND-GUIDED CANNULATION OF THE RIGHT JUGULAR VEIN, THE CAROTID ARTERY WAS MISTAKENLY CANNULATED. THE ERROR WAS NOTICED ONLY AT THE END OF THE SURGERY AND THE DEVICE WAS REMOVED AND CORRECTLY INSERTED INTO THE RIGHT JUGULAR VEIN. ON (B)(6), DOING A CONTROL RADIOGRAPHY, THEY NOTICED THE PRESENCE OF A FRAGMENT (PROBABLY OF SELDINGER) IN THE AORTA. THE FRAGMENT WAS REMOVED IN SURGERY WITHOUT COMPLICATIONS FOR THE PATIENT, WHO WAS DISCHARGED THE FOLLOWING DAY." THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17599761 ↗
• MalfunctionAug 11, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "THE GUIDE WIRE IS DEFORMED". THE GUIDEWIRE KINKED DURING USE ON THE PATIENT. AFTER GUIDEWIRE PLACEMENT AND DILATION, THE CATHETER WAS ADVANCED OVER THE GUIDEWIRE AND WHEN IT WAS WITHDRAWN IT CAME OUT KINKED. THE INSERTION SITE WAS THE FEMORAL VEIN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "NOT CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17512868 ↗
• MalfunctionJul 26, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED "DURING DILATION THE GUIDEWIRE FRACTURES AND AFTERWARD IT IS IMPOSSIBLE TO ADVANCE THE CVC, IT IS NECESSARY TO USE ANOTHER CVC". THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397066 ↗
• InjuryJun 21, 2023Crack; Air/Gas in Device; Crack; Air/Gas in Device

  THE COMPLAINT IS REPORTED AS: OBSERVATION OF A CRACK ON THE MEDIAL LINE OF CATHETER. PRESENCE OF 3 CC OF AIR BUBBLES. OBSERVED DURING THE CHECK-UP OF THE CHILD. THE CHILD HAD STABLE HEMODYNAMICS AND WAS CONSCIOUS. A CONTROL OF THE 3 LINES WAS OPERATED BY THE NURSE IN CHARGE OF THE CHILD. ON THE MEDIAL LINE, THE PRESENCE OF AIR WAS OBSERVED DURING THE INSPECTION OF THE LINE AND REFLUX CHECK. ON THE PROXIMAL LINE, THE SAME OBSERVATION WAS MADE BY THE NURSE. ON THE DISTAL LINE, REFLUX WAS FINE AND THERE WAS NO LEAK. IMMEDIATE ACTION: MEDICAL DECISION WAS MADE TO REMOVE THE CATHETER (THE PROCEDURE AND PROTOCOL WERE STRICTLY FOLLOWED UNDER BEST PRACTICE). CHILD WAS THEN PLACED UNDER OXYGEN THERAPY WITH A HIGH CONCENTRATION MASK, PLACED IN TREDELENBURG POSITION FOR 15 MINUTES. THE NURSE SUBSEQUENTLY TESTED THE CATHETER WITH SALINE SOLUTION AND FOUND A CRACK. HEAD DOCTOR WAS CONTACTED FOR ADVICE AND EXPERTISE. THEN CHILD WAS TRANSPORTED INSIDE THE EMERGENCY PEDIATRIC AMBULANCE TO THE HOSPITAL. CHILD WAS BROUGHT TO INTENSIVE CARE DEPARTMENT AND PLACED IN HYPERBARIC CHAMBER SESSION IN ORDER TO PREVENT A GAS EMBOLISM. THE FAMILY WAS PRESENT AND INFORMED.

  Patient problems: Insufficient Information

  MAUDE report 17176063 ↗

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-1119-2019 · Jan 10, 2019 · Terminated
  Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter Product Code: CD-10802 GTN: 00801902015396
• 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-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-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-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-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-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-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• 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-0657-2018 · Oct 17, 2017 · Terminated
  Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
• 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-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
• Z-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.