Portex 4947-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00351688032693), received between Sep 2, 2022 and Sep 22, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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.

• MalfunctionSep 22, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PHYSICIAN FELT THE SPINAL NEEDLE DID NOT INSERT SMOOTHLY INTO THE EPIDURAL SPACE. THE PHYSICIAN REPORTED DIFFICULTY ACHIEVING LOSS OF RESISTANCE WITH THE NEEDLE, RESULTING IN INCREASED PAIN AT THE INJECTION SITE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15468950 ↗
• MalfunctionSep 22, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PHYSICIAN FELT THE SPINAL NEEDLE DID NOT INSERT SMOOTHLY INTO THE EPIDURAL SPACE. THE PHYSICIAN REPORTED DIFFICULTY ACHIEVING LOSS OF RESISTANCE WITH THE NEEDLE, RESULTING IN INCREASED PAIN AT THE INJECTION SITE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15462480 ↗
• MalfunctionSep 2, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PHYSICIAN FELT THE SPINAL NEEDLE DID NOT INSERT SMOOTHLY INTO THE EPIDURAL SPACE. THE PHYSICIAN REPORTED DIFFICULTY ACHIEVING LOSS OF RESISTANCE WITH THE NEEDLE, RESULTING IN INCREASED PAIN AT THE INJECTION SITE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 15352000 ↗

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-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-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