Portex A4134-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20351688081664), received between Jul 13, 2020 and Jul 13, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K965017); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PER MEDWATCH.ANESTHESIOLOGY ATTEMPTED TO PLACE A L3 AND L4 EPIDURAL ON ONE ATTEMPT THERE WAS A LOSS OF RESISTANCE WHEN THE CATHETER WAS THREAD. THE ANESTHESIOLOGY FELT SOME RESISTANCE SO THEY STOPPED. THE PATIENT REPORTED A TRANSIENT RIGHT SIDE PARENTHESIS SO THEY DECIDED TO PULL THE CATHETER AND REPOSITION. THE CATHETER WAS AT 12CM AT THE TOUHY NEEDLE HUB. WHEN THE ANESTHESIOLOGY PULL THE CATHETER THEY FELT A SUDDEN SNAP. THE CATHETER BROKE OFF INSIDE THE PATIENT. THE NEEDLE SKIN WAS INSPECTED AND THE COILED WIRE WAS STILL IN THE PATIENT, IT WAS PULLED AND REMOVED. WHEN THE CATHETER WAS INSPECTED IT WAS FOUND BROKEN AT APPX 4CM. (B)(6) 2020, ADDITIONAL INFORMATION RECEIVED CUSTOMER STATED THAT THE PATIENT WAS ASSESSED BY NEUROSURGERY PRIOR TO THEIR DISCHARGE FROM THE HOSPITAL IN LATE (B)(6) 2020. THEY WERE ENCOURAGED TO FOLLOW UP IF ANY SYMPTOMS AROSE FROM THE RETAINED PIECE OF EPIDURAL CATHETER. THEIR MOST RECENT FOLLOW UP VISIT IN JUNE DID NOT REPORT ANY SYMPTOMS FROM THE RETAINED CATHETER. SAMPLE WAS NOT SAVE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 10268420 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K965017. One submission often covers many models, so check the product and lot details in each record.

• Z-1101-2026 · Dec 19, 2025 · Open, Classified
  Portex Spinal Tray, Item No. A3729-24 A3595
• Z-0211-2007 · Oct 27, 2006 · Terminated
  Portex Continuous Epidural tray Ref 4948-17
• Z-0244-06 · Nov 17, 2005 · Terminated
  4904 Glass L.O.R. Syringe
• Z-0245-06 · Nov 17, 2005 · Terminated
  4950-16 Portex Epidural Mini-pack
• Z-0243-06 · Nov 17, 2005 · Terminated
  4903 Glass L.O.R. Syringe
• Z-0242-06 · Nov 17, 2005 · Terminated
  4902 Glass L.O.R. Syringe
• Z-0166-04 · Oct 10, 2003 · Terminated
  Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20