Portex A4058-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20351688080810), received between May 11, 2018 and May 11, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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, 2018Missing Value Reason; Missing Value Reason

  IT WAS REPORTED THAT DURING USE OF A PORTEX® SPINAL ANESTHESIA TRAY SPINAL WAS SLOW TO SET UP AND A NEW DRUG WAS USED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7508280 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. IT WAS ALSO REPORTED THAT THE CLINICIAN USED TWO DIFFERENT LOT NUMBERED SPINAL TRAYS AND BOTH DID NOT MEET THE STANDARDS REQUIRED. THE CLINICIAN THEN USED AN EPIDURAL TRAY TO FINALLY COMPLETE THE PROPER NUMBING. NO GENERAL ANESTHESIA WAS REQUIRED. IT WAS SUSPECTED THAT DURING TRANSPORTATION TO FACILITY, THE PRODUCTS MAY HAVE BEEN LEFT IN A HOT PLACE WHICH LESSENED THE BUPIVACAINE EFFICACY. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507869 ↗
• MalfunctionMay 11, 2018Defective Device; Defective Device

  IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. IT WAS ALSO REPORTED THAT THE CLINICIAN USED TWO DIFFERENT LOT NUMBERED SPINAL TRAYS AND BOTH DID NOT MEET THE STANDARDS REQUIRED. THE CLINICIAN THEN USED AN EPIDURAL TRAY TO FINALLY COMPLETE THE PROPER NUMBING. NO GENERAL ANESTHESIA WAS REQUIRED. IT WAS SUSPECTED THAT DURING TRANSPORTATION TO FACILITY, THE PRODUCTS MAY HAVE BEEN LEFT IN A HOT PLACE WHICH LESSENED THE BUPIVACAINE EFFICACY. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507865 ↗

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-0245-06 · Nov 17, 2005 · Terminated
  4950-16 Portex Epidural Mini-pack
• 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-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