ARROW IPN032560Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801902095916), received between May 20, 2021 and May 20, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

1 other recall cover devices cleared under the same FDA submission (K111900); 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. 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-2159-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2021Break; Break

  CUSTOMER REPORTED "THE PEEL AWAY DOES NOT SNAP AND SPLIT. ONE OF THE TABS WILL SNAP OFF ENTIRELY LEAVING US WITH NO WAY TO PEEL THE SHEATH APART.". IT WAS REPORTED THERE WAS A DELAY IN THEAPY DUE TO THE TIME TO REMOVE AND REPLACE THE CATHETER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859826 ↗
• MalfunctionMay 20, 2021Break; Break

  CUSTOMER REPORTED "THE PEEL AWAY DOES NOT SNAP AND SPLIT. ONE OF THE TABS WILL SNAP OFF ENTIRELY LEAVING US WITH NO WAY TO PEEL THE SHEATH APART.". IT WAS REPORTED THERE WAS A DELAY IN THEAPY DUE TO THE TIME TO REMOVE AND REPLACE THE CATHETER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111900. One submission often covers many models, so check the product and lot details in each record.

• Z-1007-2015 · Feb 4, 2013 · Terminated
  The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX