ARROW IPN000158Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801902002075), received between Jan 11, 2024 and Sep 3, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 reports).

3 other recalls cover devices cleared under the same FDA submission (K924607); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "WHEN THE USER REMOVED THE DILATOR FROM THE SHEATH BEFORE USE, THE HEMOSTASIS VALVE GOT DETACHED WITH THE DILATOR. T HEREFORE, A NEW KIT WAS USED INSTEAD." THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951908 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "WHEN THE USER WAS REMOVING THE DILATOR DURING USE, THE HEMOSTASIS VALVE GOT DETACHED WITH THE DILATOR. THEREFORE, THE SHEATH WAS REMOVED AND REPLACED WITH A NEW KIT. NO INJURY TO THE PATIENT OCCURRED." 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 22730342 ↗
• MalfunctionFeb 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "THE DOCTOR FOUND SHEATH HUB 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 21332035 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "PRIOR TO THE PROCEDURE ACCORDING TO IFU, THE MD FOUND SHEATH VALVE RUBBER OUT PHENOMENON OCCURS." ASSOCIATED COMPLAINTS: 9680794-2024-00927.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246093 ↗
• MalfunctionSep 13, 2024Material Separation; Material Separation

  IT WAS REPORTED "PRIOR TO THE PROCEDURE ACCORDING TO IFU, THE MD FOUND SHEATH VALVE RUBBER OUT PHENOMENON OCCURS." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212295 ↗
• MalfunctionSep 3, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT: "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND AIR IS GENERATED DUE TO DEFECTIVE PROXIMAL HUB." THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20123558 ↗
• MalfunctionMay 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "BLOOD LEAKAGE FROM A THREE-WAY VALVE WAS FOUND." THE USER CHANGED TO A NEW SET. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219943 ↗
• MalfunctionApr 23, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD IDENTIFIED THAT VALVE BREAKAGE OCCURRED. SO THE MD OPEND UP THE NEW KIT TO FINISH THE PROCEDURE." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATEINT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164756 ↗
• MalfunctionApr 23, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED "DURING THE PROCEDURE ACCORDING TO IFU, THE MD IDENTIFIED THAT VALVE BREAKAGE OCCURRED. SO THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE." THE DEVICE WAS REMOVED AND REPLACED. 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 19164717 ↗
• MalfunctionApr 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: THE DILATOR BODY AND THE HUB SEPARATED DURING USE. THERE WAS NO PART LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETE AND THERE WAS NO INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057684 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: THE HEMOSTASIS VALVE OF THE SHEATH SNAPPED OFF AND GOT DETACHED DURING USE. THEREFORE, THE SHEATH WAS REMOVED AND REPLACED WITH A NEW KIT. NO INJURY TO THE PATIENT OCCURRED. ADDITIONAL INFORMATION: WHEN THE USER REMOVED THE CATHETER FROM THE SHEATH, A PART OF THE HEMOSTASIS VALVE GOT DETACHED AND REMOVED WITH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491976 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: THE HEMOSTASIS VALVE OF THE SHEATH SNAPPED OFF AND GOT DETACHED DURING USE. THEREFORE, THE SHEATH WAS REMOVED AND REPLACED WITH A NEW KIT. NO INJURY TO THE PATIENT OCCURRED. ADDITIONAL INFORMATION: WHEN THE USER REMOVED THE CATHETER FROM THE SHEATH, A PART OF THE HEMOSTASIS VALVE GOT DETACHED AND REMOVED WITH THE CATHETER. ASSOCIATED TO 9680794-2024-00052.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491919 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: THE HEMOSTASIS VALVE OF THE SHEATH SNAPPED OFF AND GOT DETACHED DURING USE. THEREFORE, THE SHEATH WAS REMOVED AND REPLACED WITH A NEW KIT. NO INJURY TO THE PATIENT OCCURRED. ADDITIONAL INFORMATION: WHEN THE USER REMOVED THE CATHETER FROM THE SHEATH, A PART OF THE HEMOSTASIS VALVE GOT DETACHED AND REMOVED WITH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491857 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924607. One submission often covers many models, so check the product and lot details in each record.

• Z-1064-2016 · Jan 12, 2016 · Terminated
  Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis
• Z-1491-2009 · Feb 11, 2009 · Terminated
  Arrow Super Arrow-Flex Percutaneous Sheath Introducers
• Z-0088-04 · Oct 22, 2003 · Terminated
  10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set