ARROW IPN033013Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30801902124310), received between Feb 15, 2021 and Feb 9, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT "(B)(6) 2026, (B)(6) MEDICAL CENTER REPORTED THAT LEAKAGE OCCURRED IN THE CENTRAL VENOUS CATHETER (CVC) AFTER ITS IMPLANTATION IN THE PATIENT'S BODY." 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 24291341 ↗
• MalfunctionJul 11, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "AFTER CANNULATION OF THE CENTRAL VASCULAR ACCESS TO THE PASSAGE OF THE GUIDEWIRE, THERE IS EVIDENCE OF MALFORMATION OF THE GUIDEWIRE BEFORE INSERTION, SO THAT THE CATHETER CANNOT BE USED." THIS WAS FOUND PRIOR TO USE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479221 ↗
• MalfunctionMay 12, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED "DURING CVC INSERTION OUTER SHEET OF GUIDE WIRE BROKE AND WIRE UNRAVELED. ALL PIECES INTACT AND ABLE TO REMOVE WIRE FROM PATIENT." A HEMATOMA RESULTED FROM THE OCCURRENCE. MANUAL PRESSURE WAS APPLIED AND A NEW LINE WAS INSERTED. IT WAS REPORTED "THE PATIENT REMAINS IN THE ICU FOR ILLNESS UNRELATED TO THE BROKE WIRE ISSUE".

  Patient problems: Hematoma

  MAUDE report 22003704 ↗
• MalfunctionMar 10, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "DURING INSERTION, THE DOCTOR FOUND THE SWG UNRAVELLED DURING USED ON THE PATIENT. THE CATHETER 5CM SIDE HOLE WAS FOUND BLOCK 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. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00243 AND 3006425876-2025-00242.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558729 ↗
• MalfunctionMar 10, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT "DURING INSERTION, THE DOCTOR FOUND THE SWG UNRAVELLED DURING USED ON THE PATIENT. THE CATHETER 5CM SIDE HOLE WAS FOUND BLOCK 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. THE ASSOCIATED EMDR REPORT NUMBERS ARE 3006425876-2025-00243 AND 3006425876-2025-00242.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21558723 ↗
• InjuryOct 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT "ON (B)(6) 2024, IN THE PEDIATRIC INTENSIVE CARE UNIT, THE NURSES NOTICED THAT A CHILD'S CVC WAS LEAKING UNDER THE SKIN AFTER 4 DAYS, CAUSING DISCHARGE, REDNESS AND OEDEMA." "THE CATHETER WAS REPLACED AND AFTER REMOVAL, THE SURGEON FOUND IT TO BE BLOCKED WITH A BLOOD CLOT INSIDE." IT WAS FURTHER REPORTED "THERE WAS CLINICAL DETERIORATION AT THE TIME OF THE INCIDENT LINKED TO THE POOR ADMINISTRATION OF ANTI-INFECTIVE THERAPY, BUT NOW I DON'T KNOW IF THERE ARE ANY LONG-TERM CONSEQUENCES OF THE INCIDENT. IT'S LIKELY THAT THE TREATMENT SOLVED ALL.".

  Patient problems: Skin Inflammation/ Irritation; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 20491267 ↗
• MalfunctionSep 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180204 ↗
• MalfunctionAug 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT " THE GUIDE WIRE WAS SEPARATE, OUT TO BE SPRING AND STUCK IN VEIN OF PATIENT WHILE THE DOCTOR INSERT GUIDEWIRE TO PATIENT. THEREFORE, HE HAD TO OPENED NEW SET FROM STOCK IN HOSPITAL. THE PATIENT WAS NOT INJURED." ASSOCIATED COMPLAINTS 3006425876-2024-00835 AND 3006425876-2024-00834.

  Patient problems: Foreign Body In Patient

  MAUDE report 20093756 ↗
• InjuryAug 29, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED THAT " THE GUIDE WIRE WAS SEPARATE, OUT TO BE SPRING AND STUCK IN VEIN OF PATIENT WHILE THE DOCTOR INSERT GUIDEWIRE TO PATIENT. THEREFORE, HE HAD TO OPENED NEW SET OF CS-12402 FROM STOCK IN HOSPITAL. ONLY PARTIAL GUIDEWIRE REMOVED FROM THE PATIENT. THE PATIENT WAS NOT INJURED."

  Patient problems: Foreign Body In Patient

  MAUDE report 20093687 ↗
• MalfunctionAug 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "MALE PATIENT WITH A CENTRAL VENOUS CATHETER HAS AN EXTERNAL LUMEN LEAK". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943127 ↗
• MalfunctionJul 16, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SWG KINKED IN 2 PLACES IN THE PACKAGE." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750211 ↗
• MalfunctionApr 1, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "WHEN THEY OPENED THE PACKAGE, THE SWG WAS FOUND KINKED PRIOR TO THE PATIENT." NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014396 ↗
• MalfunctionFeb 7, 2024Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SWG WAS FOUND SEPARATED DURING USE ON THE PATIENT. THE RETURNED DEVICE WAS FOUND TO BE KINKED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660395 ↗
• MalfunctionJun 21, 2023Unraveled Material; Deformation Due to Compressive Stress; Unraveled Material; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: "IN TWO INSTANCES, DYSFUNCTIONAL CATHETERS WERE FOUND, IN WHICH THE GUIDEWIRE BENT AND PRESENTED DIFFICULTY IN PASSING THROUGH. ON ONE OCCASION, IT BECAME STUCK IN THE PATIENT. NO HARM WAS CAUSED TO THE PATIENT.". THE REPORTER WAS UNAWARE OF HOW THE GUIDEWIRE WAS REMOVED FROM THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS REPORTED ON THE THIRD ATTEMPT THE CATHETER WAS SUCCESSFULLY PLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17173694 ↗
• MalfunctionJun 21, 2023Unraveled Material; Deformation Due to Compressive Stress; Unraveled Material; Deformation Due to Compressive Stress

  THE COMPLAINT IS REPORTED AS: "IN TWO INSTANCES, DYSFUNCTIONAL CATHETERS WERE FOUND, IN WHICH THE GUIDEWIRE BENT AND PRESENTED DIFFICULTY IN PASSING THROUGH. ON ONE OCCASION, IT BECAME STUCK IN THE PATIENT. NO HARM WAS CAUSED TO THE PATIENT." THE REPORTER WAS UNAWARE OF HOW THE GUIDEWIRE WAS REMOVED FROM THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS REPORTED ON THE THIRD ATTEMPT THE CATHETER WAS SUCCESSFULLY PLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17173446 ↗
• InjuryFeb 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE COMPLAINT IS REPORTED AS: A CATHETER WAS INSERTED IN THE RIGHT JUGULAR ON (B)(6) 2020 AT 7 PM. ON (B)(6) 2020 IT WAS OBSERVED THAT IT CAUSED AN EXTRAVASATION OF PRODUCT "SMOFKABIVEN". THE PATIENT WAS FOUND ON (B)(6) 2020 AT AROUND 8 AM WITH AN EDEMA OF THE RIGHT CHEEK EXTENDING TO HIS NECK. THE CATHETER REMAINED INSERTED AND HELD BY THREADS. THE INFUSION WAS STOPPED AND THE DOCTOR WAS CALLED. THE DOCTOR DECIDED TO APPLY G30% % (GLUCOSE 30%) COMPRESSES AND TO HAVE A NEW CATHETER INSERTED. THUS, ON (B)(6) AT 4:30 PM THE PATIENT RETURNED TO THE OPERATING ROOM AND A NEW CATHETER WAS INSERTED IN LEFT JUGULAR. THE EDEMA AND PAIN DISAPPEARED 3 DAYS AFTER INSERTION OF THE NEW CATHETER. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

  Patient problems: Extravasation

  MAUDE report 11329742 ↗

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-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-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-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-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-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
• 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-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

…and 9 more.