ARROW IPN030777Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 40801902127745), received between Feb 16, 2022 and Aug 29, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "INTRODUCER NEEDLE BENT". 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 20098740 ↗
• MalfunctionAug 12, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "SWG WAS HARD TO ADVANCE. WIRE WAS KINKED WHEN IT WAS REMOVED. THERE WA SNO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: Insufficient Information

  MAUDE report 19960076 ↗
• MalfunctionMay 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT: "(B)(6) 2024, THE ARS WAS FOUND TO BE LEAKING DURING USE ON THE PATIENT." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19308502 ↗
• MalfunctionJan 17, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT: (1) THE ANESTHESIOLOGY DEPARTMENT REPORTED THAT WHEN THE DOCTOR IMPLANTED THE CVC, SWG HARD TO ADVANCE. (2) CHANGE A NEW SET AND NO PATIENT HARM." THE RETURNED DEVICE WAS KINKED. ADDITIONAL INFORMATION MENTIONED THAT IT MAY HAVE BEEN KINKED WITH RESISTANCE DURING THE PROCEDURE SO COMPLAINT WAS CHANGED TO REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524986 ↗
• MalfunctionSep 12, 2023Material Separation; Physical Resistance/Sticking; Material Separation; Physical Resistance/Sticking

  IT WAS REPORTED THE SPRING WIRE GUIDE KINKED DURING USE ON THE PATIENT. THE WIRE WAS STUCK IN THE DILATOR AND DURING REMOVAL, "THE WIRE WAS BROKEN AT THE PART OUTSIDE THE PATIENT BODY". A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729882 ↗
• MalfunctionJul 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE ARROW RAULERSON SYRINGE WAS FOUND LEAKING DURING USE ON THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404590 ↗
• MalfunctionJul 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE ARROW RAULERSON SYRINGE WAS FOUND LEAKING DURING USE ON THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404479 ↗
• MalfunctionJul 5, 2023Deformation Due to Compressive Stress; Physical Resistance/Sticking; Deformation Due to Compressive Stress; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE SPRING WIRE J-TIP "HAS DENT AND ALMOST FRACTURE". THE SPRING WIRE GUIDE WAS STUCK IN THE ARROW RAULERSON SYRINGE (ARS) AND COULD NOT BE REMOVED. THE USER REMOVED THE ARS ALONG WITH THE SPRING WIRE GUIDE. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258023 ↗
• MalfunctionFeb 16, 2022Material Separation; Material Separation

  CUSTOMER REPORTED THE PUNCTURE NEEDLE HAD BROKEN BEYOND THE CONE WITHOUT EXCESSIVE FORCE BEING APPLIED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13541897 ↗
• MalfunctionFeb 16, 2022Crack; Crack

  CUSTOMER REPORTS CRACKS WITH AIR ASPIRATION IN THE CONE OF THE NEEDLE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13541815 ↗

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-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-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

…and 9 more.