Portex A3911-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20351688078152), received between May 11, 2018 and Mar 20, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2019Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED THAT THE MEDICATION WITHIN A SMITHS MEDICAL PORTEX SPINAL TRAY WAS INJECTED INTO THE PATIENT BY THE ANESTHESIOLOGIST. HOWEVER, THE PAIN MEDICATION DID NOT WORK AND GENERAL ANESTHESIA HAD TO BE USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8438246 ↗
• MalfunctionMar 20, 2019Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED THAT THE MEDICATION WITHIN A SMITHS MEDICAL PORTEX SPINAL TRAY WAS INJECTED INTO THE PATIENT BY THE ANESTHESIOLOGIST. HOWEVER, THE PAIN MEDICATION DID NOT WORK AND GENERAL ANESTHESIA HAD TO BE USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8438245 ↗
• MalfunctionMar 20, 2019Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED THAT THE MEDICATION WITHIN A SMITHS MEDICAL PORTEX SPINAL TRAY WAS INJECTED INTO THE PATIENT BY THE ANESTHESIOLOGIST. HOWEVER, THE PAIN MEDICATION DID NOT WORK AND GENERAL ANESTHESIA HAD TO BE USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8438242 ↗
• MalfunctionMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE OF A PORTEX® SPINAL ANESTHESIA TRAY THE DRUG MARCAINE WAS INEFFECTIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7507917 ↗

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-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-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