ARROW IPN030795Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902104960), received between Dec 19, 2023 and Feb 2, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Material Twisted/Bent

  IT WAS REPORTED "GUIDEWIRE KINKING". THIS WAS FOUND PRIOR TO USE. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233946 ↗
• MalfunctionOct 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED, "THE GUIDE WIRE WAS STUCK". THE USER CHANGED TO A NEW SET. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 20388166 ↗
• MalfunctionApr 1, 2024Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  IT WAS REPORTED "SWG DIFFICULT TO ADVANCE IN PATIENT, AND KINKING WHEN TOOK OUT." THE USER CHANGED TO A NEW SET. NO MEDICAL INTEVENTION REQUIRED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 19014458 ↗
• MalfunctionJan 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: CVC (CENTRAL VENOUS CATHETER) BREAKS DURING THE TURNING OF THE PATIENT IN BED. THE PATIENT HAS A CVC IN THE GROIN. THERE ARE TWO "TIPS" OR LUER, ONE WHITE AND ONE BROWN. THE WHITE LUER IS CONNECTED TO THE TPN. WHEN THE STAFF TURNS THE PATIENT, THE WHITE LUER BECOMES DETACHED FROM THE TUBING. THE TUBING IS CLAMPED USING FORCEPS. AN ANESTHESIOLOGIST IS CONTACTED AND COMES TO THE WARD TO EXAMINE THE CVK. THE CVK IS REMOVED, AND A VENOUS PORT IS ACTIVATED IN CONSULTATION WITH THE ANESTHESIOLOGIST. THE ANESTHESIOLOGIST BELIEVES THERE IS LIKELY A PROBLEM WITH THE MATERIAL. THE PATIENT EXPERIENCED DISTRESS BUT NO SYMPTOMATIC HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433702 ↗
• MalfunctionDec 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: THE CATHETER WAS BENT AFTER THE DOCTOR INSERTED AND PULLED IT OUT, CANNOT PERFORM AGAIN. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356159 ↗
• MalfunctionDec 19, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT: " THE CATHETER WAS BENT AFTER THE DOCTOR INSERTED AND PULLED IT OUT, CANNOT PERFORM AGAIN. NO PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356110 ↗

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-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-1967-2018 · Apr 11, 2018 · Terminated
  Maximal Barrier Drape; Product Code: ASK-04000-HMC
• 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-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-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-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.