Portex A2693-17/27Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00351688058006), received between Feb 23, 2017 and Feb 23, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Deliver” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2017Product Quality Problem; Failure to Deliver; Product Quality Problem; Failure to Deliver

  IT WAS REPORTED THAT A PORTEX® COMBINED SPINAL EPIDURAL SYSTEM CATHETER DID NOT HAVE A HOLE AT THE TIP AND FLUID WAS UNABLE TO BE DELIVERED. THE ISSUE WAS OBSERVED DURING A SPINAL ATTEMPT DURING A CESAREAN SECTION PROCEDURE. IT WAS NOTED THAT THIS DEVICE WAS A BACKUP EPIDURAL THAT WAS ATTEMPTED AFTER THE FIRST FAILED ATTEMPT. THE DEVICE WAS PLACED BY ANESTHESIA STAFF. IT WAS OBSERVED AFTER THE EPIDURAL CATHETER WAS REMOVED THAT IT WAS NOT PERFORATED AT THE PATIENT END, 1CM FROM THE CATHETER TIP, AS EXPECTED. GENERAL ANESTHESIA WAS ADMINISTERED TO ADDRESS THE EPIDURAL ISSUE. THE CESAREAN SECTION WAS REPORTED TO BE SUCCESSFUL. NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00483.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6354651 ↗
• InjuryFeb 23, 2017Product Quality Problem; Failure to Deliver; Product Quality Problem; Failure to Deliver

  IT WAS REPORTED THAT A PORTEX® COMBINED SPINAL EPIDURAL SYSTEM CATHETER DID NOT HAVE A HOLE AT THE TIP AND FLUID WAS UNABLE TO BE DELIVERED. THE ISSUE WAS OBSERVED DURING A SPINAL ATTEMPT DURING A CESAREAN SECTION PROCEDURE. THE DEVICE WAS PLACED BY ANESTHESIA STAFF. IT WAS OBSERVED AFTER THE EPIDURAL CATHETER WAS REMOVED THAT IT WAS NOT PERFORATED AT THE PATIENT END, 1CM FROM THE CATHETER TIP, AS EXPECTED. GENERAL ANESTHESIA WAS ADMINISTERED TO ADDRESS THE EPIDURAL ISSUE. THE CESAREAN SECTION WAS REPORTED TO BE SUCCESSFUL. NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00634.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6354650 ↗

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-0245-06 · Nov 17, 2005 · Terminated
  4950-16 Portex Epidural Mini-pack
• Z-0244-06 · Nov 17, 2005 · Terminated
  4904 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