Portex 24-1305-22Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517070347), received between Oct 9, 2024 and Nov 8, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Expulsion1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE 20ML SYRINGE IN THE PACK WAS USED TO GIVE A TOP UP EPIDURAL PRIOR TO EMERGENCY CAESAREAN SECTION, AND THE SYRINGE SPLIT/BURST. THE SPIT OCCURRED AT THE TOP OF THE SYRINGE NEAR WHERE IT WAS CONNECTED TO THE EPIDURAL FILTER. IT WAS A CRITICAL MOMENT THAT THE SYRINGE SPLIT, RESULTING IN A DELAY OF GIVING A TOP UP EPIDURAL. WHEN THE TOP UP FAILED, THE BABY NEEDED TO BE BORN SO A DECISION WAS MADE TO USE GENERAL ANESTHESIA (GA). THIS RESULTED IN THE WOMAN NOT BEING AWAKE FOR THE BIRTH OF HER BABY AND THE DAD NOT BEING PRESENT IN THEATRE. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM. THE PATIENT REQUIRED A GENERAL ANESTHESIA EMERGENCY LOWER SEGMENT CESAREAN SECTION RATHER THAN AN EPIDURAL TOP UP. THE PATIENT RECEIVED THE FOLLOWING MEDICAL TREATMENT: GA, PCA PUMP POST-DELIVERY. THIS OCCURRED WITH TWO SEPARATE PATIENTS. THIS REPORT CAPTURES THE FIRST OF TWO PATIENTS.
Patient problems: Insufficient Information
MAUDE report 20640824 ↗InjuryNov 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE 20ML SYRINGE IN THE PACK WAS USED TO GIVE A TOP UP EPIDURAL PRIOR TO EMERGENCY CAESAREAN SECTION, AND THE SYRINGE SPLIT/BURST. THE SPIT OCCURRED AT THE TOP OF THE SYRINGE NEAR WHERE IT WAS CONNECTED TO THE EPIDURAL FILTER. IT WAS A CRITICAL MOMENT THAT THE SYRINGE SPLIT, RESULTING IN A DELAY OF GIVING A TOP UP EPIDURAL. WHEN THE TOP UP FAILED, THE BABY NEEDED TO BE BORN SO A DECISION WAS MADE TO USE GENERAL ANESTHESIA (GA). THIS RESULTED IN THE WOMAN NOT BEING AWAKE FOR THE BIRTH OF HER BABY AND THE DAD NOT BEING PRESENT IN THEATRE. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM. THE PATIENT REQUIRED A GENERAL ANESTHESIA EMERGENCY LOWER SEGMENT CESAREAN SECTION RATHER THAN AN EPIDURAL TOP UP. THE PATIENT RECEIVED THE FOLLOWING MEDICAL TREATMENT: GA, PCA PUMP POST-DELIVERY. THIS OCCURRED WITH TWO SEPARATE PATIENTS. THIS REPORT CAPTURES THE SECOND OF TWO PATIENTS.
Patient problems: Insufficient Information
MAUDE report 20640704 ↗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 20410162 ↗
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-0244-06 · Nov 17, 2005 · Terminated4904 Glass L.O.R. Syringe
- Z-0245-06 · Nov 17, 2005 · Terminated4950-16 Portex Epidural Mini-pack
- Z-0242-06 · Nov 17, 2005 · Terminated4902 Glass L.O.R. Syringe
- Z-0243-06 · Nov 17, 2005 · Terminated4903 Glass L.O.R. Syringe
- 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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