ARROW IPN033064Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10801902099645), received between Sep 18, 2023 and Mar 11, 2026 — classified as 3 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (13 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Defective Device

  IT WAS REPORTED THAT "THE GUIDE ENTERS WITHOUT DIFFICULTY, BUT WHEN REMOVING THE GUIDE, IT BECOMES DEFECTIVE, PREVENTING THE CATHETER FROM PASSING THROUGH." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567765 ↗
• MalfunctionMar 4, 2026Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "ON (B)(6) 2025, CENTRAL VENOUS CATHETER (CVC) KIT WAS USED FOR CATHETERIZATION. DURING THE PROCEDURE, AFTER NEEDLE INSERTION AND WHEN ADVANCING THE GUIDEWIRE FOR APPROXIMATELY 1-2 CM, SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE GUIDEWIRE WAS THEN WITHDRAWN, AND KINKED WAS NOTED AT THE DISTAL TIP OF THE GUIDEWIRE." 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 24506816 ↗
• MalfunctionJan 15, 2026Obstruction of Flow

  IT WAS REPORTED THAT "(B)(6) 2025 FOR THERAPEUTIC PURPOSES, A CENTRAL VENOUS CATHETER (CVC) WAS INSERTED IN THE PEDIATRIC PATIENT. AFTER CVC PLACEMENT, ASPIRATION WAS PERFORMED ON THE CATHETER LUMENS, WITH POOR ASPIRATION NOTED IN THE SECONDARY LUMEN." 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 24080597 ↗
• MalfunctionJan 12, 2026Material Twisted/Bent

  IT WAS REPORTED THAT "(B)(6) 2025, WHEN THE DOCTOR OPEN THE PACKAGE, THE SWG WAS FOUND KINKED DURING PRIOR TO THE PATIENT." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037444 ↗
• MalfunctionDec 3, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "DURING INSERTION, THE SWG GOT STUCK; WHEN WITHDRAWN, THE TIP OF THE SWG WAS KINKED, WHICH MAY EASILY CAUSE PUNCTURE INJURY." THE USER CHANGED TO A NEW SET TO RESOLVE THE ISSUE. 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 23705843 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "11 NOV 2025, THE CATHETER 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 23704989 ↗
• MalfunctionNov 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT: "DURING CVC INSERTION, A GUIDEWIRE DEFECT WAS EVIDENT IN THREE SETS. TWO 4-FR CVCS AND ONE 5-FR CVC WERE ULTIMATELY USED. THIS PROLONGED THE OPERATIVE TIME." THERE WAS A DEFORMITY IN THE DISTAL PART OF THE GUIDE. THIS PROLONGED THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "HOSPITALIZED". ASSOCIATED MDR NUMBER INCLUDES: 9680794-2025-00959, 9680794-2025-00961, AND 9680794-2025-00960.

  Patient problems: Insufficient Information

  MAUDE report 23583163 ↗
• MalfunctionNov 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT: "DURING CVC INSERTION, A GUIDEWIRE DEFECT WAS EVIDENT IN THREE SETS. TWO 4-FR CVCS AND ONE 5-FR CVC WERE ULTIMATELY USED. THIS PROLONGED THE OPERATIVE TIME." THERE WAS A DEFORMITY IN THE DISTAL PART OF THE GUIDE. THIS PROLONGED THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "HOSPITALIZED". ASSOCIATED MDR NUMBER INCLUDES: 9680794-2025-00959, 9680794-2025-00961, AND 9680794-2025-00960.

  Patient problems: Insufficient Information

  MAUDE report 23582674 ↗
• MalfunctionNov 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT: "DURING CVC INSERTION, A GUIDEWIRE DEFECT WAS EVIDENT IN THREE SETS. TWO 4-FR CVCS AND ONE 5-FR CVC WERE ULTIMATELY USED. THIS PROLONGED THE OPERATIVE TIME." THERE WAS A DEFORMITY IN THE DISTAL PART OF THE GUIDE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "HOSPITALIZED". ASSOCIATED MDR NUMBER INCLUDES: 9680794-2025-00959, 9680794-2025-00961, AND 9680794-2025-00960.

  Patient problems: Insufficient Information

  MAUDE report 23582613 ↗
• MalfunctionJun 16, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED "DURING THE CENTRAL VENOUS CATHETER PLACEMENT PROCESS IN THE OPERATING ROOM, THE FLEXIBLE METAL GUIDEWIRE REPEATEDLY BENT AS IT WAS INSERTED, IMPEDING ITS PROGRESS AND THUS PREVENTING FURTHER PLACEMENT. THEREFORE, AN ADDITIONAL CATHETER HAD TO BE USED. THE PROCEDURE WAS PROLONGED, AND SEVERAL PUNCTURE ATTEMPTS WERE REQUIRED". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DECEASED". IT WAS REPORTED THE PATIENT'S DEATH IS UNRELATED TO THE DEVICE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22212451 ↗
• MalfunctionJan 7, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE CATHETER WAS INSERTED PRIOR TO THE PLANNED SURGICAL PROCEDURE. DURING THE INSERTION, AN ISSUE WAS ENCOUNTERED WITH THE SGW, AS THE SGW BENT WHILE ADVANCING THE DILATOR ALONG IT. THEN THE SKIN WAS INCISED. THE SECOND DILATATOR WAS USED TO COMPLETE THE PROCEDURE OF INSERTING THE CATHETER. THE PROCEDURE WAS COMPLETED, AND THE X-RAY CONFIRMED THE POSITIONING OF THE CATHETER TIP AS CORRECT". THERE WAS NO THERAPY DELAYED AND THE PATIENT HAD NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093240 ↗
• MalfunctionDec 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "FRAGILE CATHETER, BENDS UPON INSERTION. 5 CATHETERS WERE USED BEFORE ACHIEVING THE INSERTION". ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20853066 ↗
• MalfunctionDec 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "FRAGILE CATHETER, BENDS UPON INSERTION. 5 CATHETERS WERE USED BEFORE ACHIEVING THE INSERTION". ASSOCIATED COM PLAINTS 9680794-2024-01202, 9680794-2024-01208, 9680794-2024-01210, AND 9680794-2024-01209.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852938 ↗
• MalfunctionDec 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "FRAGILE CATHETER, BENDS UPON INSERTION. 5 CATHETERS WERE USED BEFORE ACHIEVING THE INSERTION". ASSOCIATED COM PLAINTS 9680794-2024-01202, 9680794-2024-01208, 9680794-2024-01211 AND 9680794-2024-01209.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852869 ↗
• MalfunctionDec 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "FRAGILE CATHETER, BENDS UPON INSERTION. 5 CATHETERS WERE USED BEFORE ACHIEVING THE INSERTION". ASSOCIATED COMPLAINTS 9680794-2024-01208, 9680794-2024-01210, 9680794-2024-01211 AND 9680794-2024-01209.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852844 ↗
• MalfunctionDec 5, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: "FRAGILE CATHETER, BENDS UPON INSERTION. 5 CATHETERS WERE USED BEFORE ACHIEVING THE INSERTION". ASSOCIATED COM PLAINTS 9680794-2024-01202, 9680794-2024-01208, 9680794-2024-01210, 9680794-2024-01211 AND 9680794-2024-01209.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852838 ↗
• MalfunctionNov 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "ACCORDING TO THE REPORT BY SURGEON, THE GUIDE WIRES FRAYED AND BECAME ENTANGLED DURING THE PROCEDURE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-01078.

  Patient problems: Insufficient Information

  MAUDE report 20585448 ↗
• MalfunctionNov 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED "ACCORDING TO THE REPORT BY SURGEON, THE GUIDE WIRES FRAYED AND BECAME ENTANGLED DURING THE PROCEDURE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 9680794-2024-01079.

  Patient problems: Insufficient Information

  MAUDE report 20585429 ↗
• MalfunctionOct 29, 2024Difficult to Remove; Material Twisted/Bent; Physical Resistance/Sticking; Separation Problem; Difficult to Remove; Material Twisted/Bent; Physical Resistance/Sticking; Separation Problem

  IT WAS REPORTED "AT THE END OF THE INSERTION OF THE CVC, IMPOSSIBLE TO REMOVE THE SWG DESPITE FLUSHING AS INDICATED FOR THIS ISSUE. DEVICE IS REPLACED." ADDITIONAL INFORMATION RECEIVED REPORTS "NO KINKING OF THE GUIDEWIRE OR NEEDLE ON INSERTION OF THE GUIDEWIRE,BUT ON THE FIRST ATTEMPT THE CATHETER WENT JUGULAR AND NOT CARDIAC. SO THERE WAS A PARTIAL REMOVE OF THE GUIDEWIRE TO REDIRECT IT. THERE WAS OBSERVED A SLIGHT KINK OF THE GUIDEWIRE AT THIS POINT. BUT THERE WAS NO DIFFICULTY IN REDIRECTING THE GUIDEWIRE, BUT ONCE POSITIONED IT WAS IMPOSSIBLE TO SEPARATE THE NEEDLE FROM THE GUIDEWIRE." A NEW CATHETER WAS INSERTED WITHOUT DIFFICULTY. THERE WAS NO CLINICAL CONSEQUENCES FOR THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558351 ↗
• MalfunctionOct 14, 2024Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT "BROWN LUMEN WAS RUNNING D5W, AND AN INFUSION PUMP BEGAN ALARMING FOR A LINE OCCLUSION. THE CARE TEAM ATTEMPTED TO FLUSH LINE WITH 10CC SYRINGE OF NORMAL SALINE AND WAS UNSUCCESSFUL IN RESOLVING THE LINE OCCLUSION. THE CARE TEAM ATTEMPTED TO INSTILL ALTEPLASE INTO LINE BUT WERE NOT ABLE TO PUSH THE CONTENTS OF THE SYRINGE. THE CARE TEAM PARTIALLY PEELED BACK THE DRESSING AND TRIED TO FLUSH THE LINE. IT WAS NOTICED THAT THE BROWN LUMEN LINE WAS BULGING WHEN ATTEMPTING TO FLUSH. AS REPORTED BY THE CARE TEAM, THE LINE APPEARED TO BE DEFECTIVE. MEDICATIONS WERE TRANSFERRED TO THE WHITE LUMEN WHICH REMAINED PATENT." 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 20442241 ↗
• MalfunctionOct 7, 2024Stretched; Material Deformation; Stretched; Material Deformation

  IT WAS REPORTED "NOTICED THAT WHEN FLUSHING CNS IN THE DISTAL BROWN LUMEN THAT NOTHING WOULD FLUSH UPON INSPECTION THE TUBE CLOSEST TO THE WHITE HUB WHERE THE TWO LUMEN JUCTED LOOKS LIKE TUBING INFLATED. THE CVC NEEDED TO BE REMOVED." ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, HOWEVER FURTHER DETAILS HAS NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20384495 ↗
• MalfunctionMay 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "THE DOCTOR FOUND THE CATHETER LEAKING DURING USE ON THE PATIENT." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENITON REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350558 ↗
• MalfunctionMay 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT: "(B)(6) 2024, THE CATHETER TIP WAS FOUND DEFORMED DURING USE ON THE PATIENT. THE PATIENT WAS REPROTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298602 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, "THE GUIDE WAS BENT". 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 19281970 ↗
• MalfunctionMar 21, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "IT IS REPORTED THAT THE CATHETER GUIDE GETS STUCK IN THE NEEDLE AND DOES NOT COME OUT, GENERATING RESISTANCE". ADDITIONAL INFORMATION: THE GUIDE WIRE WAS KINKED. THE ISSUE WAS IDENTIFIED PRIOR TO USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948062 ↗

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-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-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-0650-2018 · Oct 17, 2017 · Terminated
  Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; 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

…and 9 more.