ARROW IPN000159Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801902002082), received between Feb 2, 2024 and Mar 7, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND THE SHEATH LEAK 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 21548465 ↗
• MalfunctionOct 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "ON (B)(6) 2024, THE DOCTOR FOUND THE SHEATH SHIM DAMAGED AND LEAKING DURING USE ON THE PATIENT." THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459727 ↗
• MalfunctionFeb 14, 2024Material Separation; Material Separation

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE RUBBER SEAL FELL OFF. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THIS DEFECT WAS FOUND PRIOR TO USE. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707399 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND THE RUBBER SEAL FELL OFF. SO THE MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE." THE MALFUNCTION WAS FOUND PRIOR TO USE DURING INSPECTION. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681542 ↗
• MalfunctionFeb 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "WHEN FLUSHING THE DEVICE, THE WHITE PLASTIC EDGE THAT ALLOWS THE INTRODUCTION OF THE SWG AND THE CATHETERS WITHOUT ARTERIAL REFLUX, SEPARATES AND FELL OFF. CLINICAL CONSEQUENCES: AS THE INTRODUCER CANNOT BE USED, A SECOND INTRODUCER OF SAME LOT WAS USED WITHOUT ANY INCIDENT. THE MEDICAL STAFF REPORTED THAT A SIMILAR INCIDENT HAPPENED A FEW DAYS AGO BUT THE LOT NUMBER WAS NOT RECORDED.". THE ISSUE WAS IDENTIFIED PRIOR TO USE, THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637358 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "WHEN FLUSHING THE DEVICE, THE WHITE PLASTIC EDGE THAT ALLOWS THE INTRODUCTION OF THE SWG AND THE CATHETERS WITHOUT ARTERIAL REFLUX, SEPARATES AND FELL OFF. CLINICAL CONSEQUENCES: AS THE INTRODUCER CANNOT BE USED, A SECOND INTRODUCER OF SAME LOT WAS USED WITHOUT ANY INCIDENT. THE MEDICAL STAFF REPORTED THAT A SIMILAR INCIDENT HAPPENED A FEW DAYS AGO BUT THE LOT NUMBER WAS NOT RECORDED.". THE ISSUE WAS IDENTIFIED PRIOR TO USE, THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629674 ↗

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

…and 9 more.