ARROW IPN031499Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801902108418), received between Nov 1, 2023 and Aug 11, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND CATHETER 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 22771555 ↗
• MalfunctionAug 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "(B)(6) 2025, THE DOCTOR FOUND ARS 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 22725776 ↗
• MalfunctionApr 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED " ON (B)(6) 2025, THE INSERTION SITE WAS LEFT SIDE OF THE CHEST, DURING THE INSERTION, THE DOCTOR FOUND ARS LEAK DURING USE ON THE PATIENT." THE USER CHANGED TO A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21832633 ↗
• MalfunctionMar 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "THE DOCTOR FOUND 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 21642079 ↗
• MalfunctionNov 25, 2024Unraveled Material; Unraveled Material

  IT WAS REPORTED "ON (B)(6) 2024, BEFORE INSERTION, THE DOCTOR FOUND THE SWG UNRAVELED PRIOR TO THE PATIENT. THEY CHANGED A NEW ONE. NO HARM FOR THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772291 ↗
• MalfunctionNov 8, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED WHEN SWG INSERTION INTO ARS, DILATOR TIP WAS FOUND BLUNT DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE:3006425876-2024-01085.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642343 ↗
• MalfunctionNov 8, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED WHEN SWG INSERTION INTO ARS, DILATOR TIP WAS FOUND BLUNT DURING USE ON THE PATIENT. THEY CHANGED A NEW ONE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE:3006425876-2024-01136.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642311 ↗
• MalfunctionNov 8, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED WHEN SWG INSERTION INTO ARS, DILATOR TIP WAS FOUND BLUNT DURING USE ON THE PATIENT. THEY CHANGED TO A NEW ONE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR INCLUDES: 3006425876-2024-01084.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641724 ↗
• MalfunctionNov 8, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SWG KINKED WHEN SWG INSERTION INTO ARS, DILATOR TIP WAS FOUND BLUNT DURING USE ON THE PATIENT. THEY CHANGED TO A NEW ONE." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR INCLUDES:3006425876-2024-01137.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641555 ↗
• MalfunctionJun 5, 2024Material Separation; Material Separation

  IT WAS REPORTED "THE DOCTOR FOUND THE SWG SEPARATED PRIOR TO THE PATIENT." THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469116 ↗
• MalfunctionMay 17, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT: "(B)(6) 2024, THE DOCTOR FOUND THE SYRINGE/NEEDLE CONNECTION NOT SECURE DURING USE ON THE PATIENT." THE PATIENT WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339605 ↗
• MalfunctionMay 9, 2024Material Deformation; Material Deformation

  IT WAS REPORTED "THE DILATOR TIP WAS FOUND DAMAGED DURING USE ON THE PATIENT." A NEW DILATOR WAS USED TO COMPLETE THE PROCEDURE. 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 19279798 ↗
• MalfunctionDec 19, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT: (B)(6) 2023,THE DOCTOR FOUND THE SWG DIFFFICULT TO ADVANCE PRIOR TO THE PATIENT IN THE CLINICAL ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355879 ↗
• MalfunctionNov 6, 2023Unsealed Device Packaging; Material Puncture/Hole; Unsealed Device Packaging; Material Puncture/Hole

  IT IS REPORTED THAT: A SMALL HOLE WAS FOUND IN THE PACKAGING WHICH RESULTED IN THE DEVICE NOT BEING STERILE. IT WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. IT WAS DECIDED THAT THE COMPLAINT WAS REPORTABLE AFTER INVESTIGATION OF THE RETURNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072812 ↗
• MalfunctionNov 1, 2023Unsealed Device Packaging; Material Puncture/Hole; Unsealed Device Packaging; Material Puncture/Hole

  IT WAS REPORTED THAT: (B)(6) 2023, A HOLE WAS FOUND IN THE PACKAGE PRIOR TO USE EFFECTING STERILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047957 ↗

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

…and 9 more.