Portex A3939-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20351688079005), received between May 22, 2017 and May 11, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. AS A RESULT OF THIS, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507878 ↗
• InjuryMay 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A SPINAL BLOCK FAILED DURING USE OF A PORTEX® SPINAL TRAY. THE PATIENT WAS UNDERGOING A CAESAREAN SECTION AT THE TIME OF THE EVENT. THE PATIENT'S LEGS WENT NUMB, BUT A FULL BLOCK COULD NOT BE ACCOMPLISHED. THE DOCTOR REPORTED GOOD VISUALIZATION OF CEREBROSPINAL FLUID. THE DOCTOR USED GENERAL ANESTHESIA TO FINISH THE PROCEDURE. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01070.

  Patient problems: Awareness During Anesthesia

  MAUDE report 6581280 ↗
• InjuryMay 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A SPINAL BLOCK FAILED DURING USE OF A PORTEX® SPINAL TRAY. THE PATIENT WAS UNDERGOING A CAESAREAN SECTION AT THE TIME OF THE EVENT. THE PATIENT'S LEGS WENT NUMB, BUT A FULL BLOCK COULD NOT BE ACCOMPLISHED. THE DOCTOR REPORTED GOOD VISUALIZATION OF CEREBROSPINAL FLUID. THE DOCTOR USED GENERAL ANESTHESIA TO FINISH THE PROCEDURE. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01072.

  Patient problems: Awareness During Anesthesia

  MAUDE report 6581270 ↗

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-0242-06 · Nov 17, 2005 · Terminated
  4902 Glass L.O.R. Syringe
• Z-0243-06 · Nov 17, 2005 · Terminated
  4903 Glass L.O.R. Syringe
• 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-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