ARROW IPN040048Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902005097), received between Dec 9, 2021 and Dec 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K801912); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  EPIDURAL CATHETERIZATION KIT BROKE MID PROCEDURE. CUSTOMER WAS DOING A CAUDAL EPIDURAL AND IN THE LAST PART OF THE PROCEDURE THE CUSTOMER NOTICED A FAILURE IN THE WALL OF THE CATHETER SPECIFICALLY. THE CONTRAST SHOWED BALLOONING OF THE WALL. THE CUSTOMER WAS ABLE TO RETRIEVE THE CATHETER WITH NO ADVERSE OUTCOME TO THE PATIENT THAT THEY ARE AWARE OF. ON FURTHER INSPECTION OF THE CATHETER POST-PROCEDURE THEY NOTICED A LONGITUDINAL TEAR IN THE WALL OF THE CATHETER. DUE TO SEVERITY OF THE ISSUE, THE CUSTOMER IS REQUESTING IMMEDIATE FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967573 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K801912. One submission often covers many models, so check the product and lot details in each record.

• Z-2364-2026 · Apr 21, 2026 · Open, Classified
  Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G CTH, 17Gx4CM NDL/AB-19604-KS; STIMUCATH SFTY KIT: 19G CTH, 17Gx8CM NDL/AB-19608-KS;
• Z-2803-2020 · Jul 6, 2020 · Terminated
  Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
• Z-1175-2020 · Jan 15, 2020 · Terminated
  TheraCath Epidural Catheterization Kit, Product Code ASK-05001-SLR1
• Z-1249-2020 · Dec 20, 2019 · Terminated
  Arrow EPIDURAL CATHETERIZATION KIT CK-02220
• Z-1247-2020 · Dec 20, 2019 · Terminated
  Arrow EPIDURAL CATHETERIZATION KIT JH-05500
• Z-1246-2020 · Dec 20, 2019 · Terminated
  Arrow EPIDURAL CATHETERIZATION KIT YC-02220
• Z-1248-2020 · Dec 20, 2019 · Terminated
  Arrow EPIDURAL CATHETERIZATION KIT AM-05500
• Z-1251-2020 · Dec 20, 2019 · Terminated
  Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
• Z-1245-2020 · Dec 20, 2019 · Terminated
  Arrow EPIDURAL CATHETERIZATION KIT AK-05000
• Z-2012-2018 · Apr 11, 2018 · Terminated
  TheraCath(R) Epidural Catheter; Product Code: EC-05000