Portex 24-1304-22Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517070330), received between Oct 9, 2024 and Mar 19, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Expulsion1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
IT WAS REPORTED THAT THE EPIDURAL CATHETER WAS FOUND INCOMPLETE AFTER AN EPIDURAL ATTEMPT DURING THE NIGHT SHIFT AND WAS REMOVED WHILE WAS STILL PASSING THROUGH THE TUOHY NEEDLE, SUBSEQUENTLY REALIZING THAT IT HAD 5.5 CM MISSING FROM THE END. THE INCIDENT OCCURRED WHILE REMOVING THE EPIDURAL NEEDLE WHICH MADE IT TO SHEAR OFF DUE TO THE DIFFICULT REPOSITION. THERE WAS 4CM OF CATHETER TUBING REMAINING IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21647097 ↗MalfunctionOct 9, 2024Expulsion; Expulsion
IT WAS REPORTED THAT THE PISTON WAS PULLED OUT FROM THE SYRINGE VERY EASY, THERE WAS NO STOP. FENESTRATED DRAPE ISSUE, THEY WONDER ABOUT THE ADHESIVE STRIP, WHY IT IS NOT MORE ON THE EDGE. NOW THE DRAPE FALLS OVER THE FENESTRATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410282 ↗
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, ClassifiedPortex Spinal Tray, Item No. A3729-24 A3595
- Z-0211-2007 · Oct 27, 2006 · TerminatedPortex Continuous Epidural tray Ref 4948-17
- Z-0243-06 · Nov 17, 2005 · Terminated4903 Glass L.O.R. Syringe
- Z-0242-06 · Nov 17, 2005 · Terminated4902 Glass L.O.R. Syringe
- Z-0244-06 · Nov 17, 2005 · Terminated4904 Glass L.O.R. Syringe
- Z-0245-06 · Nov 17, 2005 · Terminated4950-16 Portex Epidural Mini-pack
- Z-0166-04 · Oct 10, 2003 · TerminatedPortex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20
Other Anesthesia conduction kit devices
- BD Luer-Lok, BD Glaspak 405671Becton, Dickinson And Company · Anesthesia conduction kit1 recall68 reports
- ARROW IPN922678Teleflex Incorporated · Anesthesia conduction kit2 recalls0 reports
- BD Luer-Lok, BD Glaspak 405672Becton, Dickinson And Company · Anesthesia conduction kit1 recall27 reports
- BD Luer-Lok, BD Glaspak 405673Becton, Dickinson And Company · Anesthesia conduction kit1 recall10 reports
- BD Luer-Lok, BD Glaspak 405637Becton, Dickinson And Company · Anesthesia conduction kit1 recall7 reports
- BD Luer-Lok, BD Glaspak 405707Becton, Dickinson And Company · Anesthesia conduction kit1 recall4 reports
- BD Glaspak 405675Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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