Portex NLD-15597C-20Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20351688078701), received between May 11, 2018 and May 11, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Defective Device” (4 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
Device problems
- Defective Device4
Patient problems
- No Consequences Or Impact To Patient3
- Patient Problem/Medical Problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS INCOMPLETE/FAILED SPINAL BLOCK AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508012 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS INCOMPLETE/FAILED SPINAL BLOCK AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508011 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT THERE WAS FAILED SENSORY BLOCK WITH BUPIVACAINE MEDICATION IN PORTEX® SPINAL KIT. NO PATIENT INJURY REPORTED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7507918 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT THE BUPIVACAINE CONTAINED IN THE PORTEX® SPINAL ANESTHESIA TRAY WAS INEFFECTIVE. THE PROCEDURE WAS REPEATED WITH BUPIVACAINE OBTAINED FROM THE HOSPITAL SUPPLY. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507803 ↗
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-0242-06 · Nov 17, 2005 · Terminated4902 Glass L.O.R. Syringe
- Z-0243-06 · Nov 17, 2005 · Terminated4903 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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