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ARROW IPN038178Recalls & reported problems

Teleflex Incorporated · TheraCath(R) Epidural Catheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902139778), received between Apr 19, 2021 and Apr 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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

Device problems

  • No Flow1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 19, 2021No Flow; No Flow

    DOCTOR FOUND THE LIQUID MEDICINE COULD NOT BE INJECTED INTO THE CATHETER, CATHETER BLOCKED DURING EPIDURAL SURGERY ON PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11685914 ↗

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-1246-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT YC-02220
  • Z-1245-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT AK-05000
  • Z-1248-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT AM-05500
  • Z-1249-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT CK-02220
  • Z-1251-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
  • Z-1247-2020 · Dec 20, 2019 · Terminated
    Arrow EPIDURAL CATHETERIZATION KIT JH-05500
  • Z-2012-2018 · Apr 11, 2018 · Terminated
    TheraCath(R) Epidural Catheter; Product Code: EC-05000

Other Anesthesia conduction kit devices

All Anesthesia conduction kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.