ARROW IPN030759Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801902000415), received between Jul 22, 2024 and Apr 15, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Material Separation

  IT WAS REPORTED THAT "WHEN THE GUIDE WIRE WAS INSERTED, IT WOULDN'T GO THROUGH, AND WHEN THE GUIDE WIRE WAS REMOVED, IT BROKE AND OPENED UP, LEAVING PIECES OF THE WIRE IN THE CATHETER. IT WAS FIRST TRIED WITH THE CS-14402 AND THEN WITH THE CS-14403, HAVING THE SAME ISSUE WITH BOTH CVC". ANOTHER WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY TO THERAPY. THERE WAS NO PATIENT COMPLICATIONS OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL". ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2026-00301.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887378 ↗
• MalfunctionMay 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING INSERTION, WHEN THEY RETRACTED THE GUIDEWIRE, IT WAS KINKED. THEY OPENED A SECOND CVC AND HAD THE SAME PROBLEM. IT WAS HARD TO REMOVE 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". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00440 AND 3006425876-2025-00486.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984577 ↗
• MalfunctionMay 7, 2025Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED "DURING INSERTION, WHEN THEY RETRACTED THE GUIDEWIRE, IT WAS KINKED. THEY OPENED A SECOND CVC AND HAD THE SAME PROBLEM. IT WAS HARD TO REMOVE THE GUIDEWIRE." THE DEVICE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00486 AND 3006425876-2025-00440.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977643 ↗
• MalfunctionJul 22, 2024Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "DURING CENTRAL VENOUS CATHETER PLACEMENT IN THE SURGERY ROOM.WHEN THE BLOOD VESSEL IS CANALIZED AND THE METAL GUIDE IS PASSED, IT GETS STUCK IN THE NEEDLE. THEY WERE FORCED TO REMOVE IT OUT OF THE BLOOD VESSEL AND WHEN THE METAL GUIDE IS REMOVED, THE DEFORMATION OF THE METAL GUIDE IS OBSERVED".

  Patient problems: Insufficient Information

  MAUDE report 19794021 ↗

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-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
• 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-0657-2018 · Oct 17, 2017 · Terminated
  Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018

…and 9 more.