ARROW IPN040139Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50801902126370), received between Jan 24, 2020 and Jan 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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.

• MalfunctionJan 24, 2020Defective Device; Material Twisted/Bent

  THERE WAS 2 CATHETERS WHICH ARE DEFECTIVE; ONE WAS BENT AND THE SECOND ONE SHREDDED. PER THE DOCTOR'S OPERATIVE NOTE: PREOP DIAGNOSIS: CERVICAL RADICULOPATHY. POSTOP DIAGNOSIS: CERVICAL RADICULOPATHY. PROCEDURE PLANNED: EPIDURAL STEROID INJECTION AT THE C7-T1 INTERSPACE, FLUOROSCOPIC GUIDANCE. THE SITE OF PAIN AND PROCEDURE WERE CONFIRMED PRIOR TO STARTING THE PROCEDURE. THE TARGET INTERSPACE WAS IDENTIFIED. THE SKIN OVERLYING THE TARGET AREA WAS PREPPED WITH CHLORHEXIDINE AND STERILELY DRAPED. LOCAL ANESTHESIA WAS OBTAINED WITH 3.0 ML OF PRESERVATIVE FREE 1% LIDOCAINE. USING A 20-GAUGE TUOHY NEEDLE WITH A LOSS-OF-RESISTANCE TO NORMAL SALINE AND HANGING DROP TECHNIQUE, THE EPIDURAL SPACE WAS LOCATED. ASPIRATION WAS NEGATIVE FOR BLOOD OR CSF. SUBSEQUENTLY 1 ML OF LOPAMIDOL 240M CONTRAST WAS INJECTED DEMONSTRATING APPROPRIATE EPIDURAL SPREAD. LOCAL ANESTHETIC TEST DOSE WAS NEGATIVE FOR INTRATHECAL INJECTION. 10MG DEXAMETHASONE WAS SUSPENDED IN 4ML OF PRESERVATIVE FREE NORMAL SALINE WAS EASILY INJECTED INTO THE EPIDURAL SPACE WITHOUT APPARENT COMPLICATION. THE TUOHY NEEDLE WAS THEN CLEARED WITH PRESERVATIVE FREE 1% LIDOCAINE AND REMOVED. THE SKIN WAS CLEANSED AND THE PATIENT RETURNED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9626891 ↗

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