ARROW IPN920509Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10801902199659), received between Apr 2, 2026 and Apr 22, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 10, 2026Open, Classified

   16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

   Z-2157-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT: "THE MATERIAL NUMBER ON THE SECONDARY PACKAGING WAS DIFFERENT FROM PRIMARY PACKAGING AND THE PRODUCT WAS DIFFERENT THAN WHAT WAS REGULARLY BEEN USED BY THE DOCTOR. SO THE CLINICIAN HAD TO USE ANOTHER TO COMPLETE PERMCATH INSERTION PROCEDURE FOR PATIENT UNDERGOING DIALYSIS.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954540 ↗
• MalfunctionApr 20, 2026Material Deformation

  IT WAS REPORTED THAT: "A LONG-TERM DIALYSIS CATHETER WAS USED INTRAOPERATIVELY TO ESTABLISH ACCESS FOR BLOOD PURIFICATION THERAPY. DURING THE PROCEDURE THE OUTER LAYER OF THE PEEL-AWAY SHEATH TORE, AND THE SHEATH COULD NOT BE INSERTED. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923599 ↗
• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED THAT" ON (B)(6) 2026, THE DOCTOR FEEDBACK AFTER A PERIOD OF USE THE EXTENSION LINE WAS FOUND DEFORMED DURING USED ON THE PATIENT. " ASSOCIATED COMPLAINTS 9680794-2026-00237, 9680794-2026-00236.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763263 ↗
• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED THAT" ON (B)(6) 2026, THE DOCTOR FEEDBACK AFTER A PERIOD OF USE THE EXTENSION LINE WAS FOUND DEFORMED DURING USED ON THE PATIENT. " ASSOCIATED COMPLAINTS 9680794-2026-00237 AND 9680794-2026-00238.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763260 ↗
• MalfunctionApr 2, 2026Material Deformation

  IT WAS REPORTED THAT"06 MAR 2026, THE DOCTOR FEEDBACK AFTER A PERIOD OF USE THE EXTENSION LINE WAS FOUND DEFORMED DURING USED ON THE PATIENT. " ASSOCIATED COMPLAINTS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763242 ↗