ARROW IPN000157Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801902002051), received between Jul 10, 2023 and Oct 8, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Break; Break

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND DILATOR TIP BROKEN. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." 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 23247759 ↗
• MalfunctionFeb 25, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND NO REGURGE DUE TO VALVE BREAKDOWN. SO, THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE.". THE PATIENT HAD NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457105 ↗
• MalfunctionFeb 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND DILATOR SPLIT. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21305121 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND DILATOR BROKEN. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." 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 20793160 ↗
• MalfunctionMay 20, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD THE THE DILATOR WAS BROKEN. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE SECOND KIT WAS USED SUCCESSFULLY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350379 ↗
• MalfunctionJan 5, 2024Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED THAT: DURING THE PROCEDURE ACCORDING TO IFU, MD FOUND THAT DILATOR WAS BROKEN. SO MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18453470 ↗
• MalfunctionAug 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THE SHEATH WAS INSERTED INTO THE FEMORAL VEIN, AND WHEN REMOVING THE DILATOR THE HEMOSTATIC VALVE CAME OUT WITH IT, CAUSING BLEED BACK. THERE WAS NO HARM TO THE PATIENT. THE ISSUE WAS RESOLVED BY USING A DIFFERENT BRAND OF SHEATH. THE PATIENT WAS "STABLE AND FINE WHEN THE CASE FINISHED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434170 ↗
• InjuryJul 10, 2023Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED DURING A SCHEDULED PERICARDIOCENTESIS, THE WIRE WAS INSERTED ALONG THE DILATOR AND WHEN TRYING TO REMOVE THE WIRE IT BECAME STUCK ALONG WITH THE DILATOR. THE PHYSICIAN IN THE EP LAB "ATTEMPTED TO REMOVE THE SHEATH IT WAS WRAPPED UP AROUND ITSELF CREATING A KNOT IN THE PERICARDIUM". THE PHYSICIAN SUGGESTED IT BE REMOVED IN THE OPERATING ROOM. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17286569 ↗

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-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-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-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.