ARROW IPN035875Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801902080257), received between May 6, 2022 and Sep 25, 2023 — classified as 3 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K122854); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Break; Break

  IT WAS REPORTED THE PEEL-AWAY SHEATH DID NOT PEEL CORRECTLY. THE SHEATH PEELED PART WAY AND THEN THE WHITE HANDLES BROKE AWAY FROM THE REST OF THE SHEATH THAT WAS AROUND THE PICC. THE CLINICIAN WAS ABLE TO USE A HEMOSTAT AND PEEL-AWAY ONE SIDE OF THE SHEATH TO GET IT OFF OF THE INDWELLING LINE. THE PICC WAS COMPLETED WITHOUT INCIDENT AFTER REMOVING THE BROKEN PEEL-AWAY. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. ADDITIONAL INFORMATION RECEIVED STATES THE INSERTER REPORTED THE WHITE HANDLE BROKE OFF IMMEDIATELY UPON APPLYING PRESSURE. THE HANDLE SEPARATED FROM THE BODY OF THE SHEATH BEFORE THE SHEATH STARTED "PEELING APART".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808625 ↗
• MalfunctionSep 22, 2023Break; Break

  IT WAS REPORTED "INSERTERS FEARED THEY LOST IN PATIENT BUT IT WAS RECOVERED. TOLD THEY ARE INCREDIBLY FLIMSY." NO MEDICAL INTERVENTION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798143 ↗
• MalfunctionMay 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  PEEL-AWAY SHEATH PREMATURELY BROKE AWAY FROM THE WINGS AS THE NURSE WAS PEELING IT FROM THE CATHETER. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307003 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122854. One submission often covers many models, so check the product and lot details in each record.

• Z-2699-2017 · Jun 12, 2017 · Terminated
  Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
• Z-0207-2016 · Oct 16, 2015 · Terminated
  ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS