Portex NLD-15597-20Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Portex spinal anesthesia kit is used to deliver numbing medication during surgery. The 32 reports mostly describe medication in the kit not working or not lasting as long as expected, so the numbing effect wore off and general anesthesia was sometimes needed instead; 27 reports cite device malfunctions and 5 cite failure to infuse. No deaths were reported and 5 injuries were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 20351688078688), received between Apr 17, 2017 and May 11, 2018 — classified as 5 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Defective Device” (21 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 Device21
- Failure to Infuse5
- Defective Component3
- Insufficient Device Problem Information2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- No Consequences Or Impact To Patient26
- Underdose3
- Inadequate Pain Relief2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A SPINAL MEDICATION IN PORTEX® SPINAL KITS DID NOT LAST AS LONG AS EXPECTED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508236 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS FAILING ON PATIENT. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508229 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508221 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508217 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508216 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508191 ↗MalfunctionMay 11, 2018Defective Component; Defective Component
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508176 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508167 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508127 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508126 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508121 ↗MalfunctionMay 11, 2018Defective Component; Defective Component
IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508115 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508051 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508039 ↗MalfunctionMay 11, 2018Defective Component; Defective Component
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE IN NUMBING THE UPPER BODY PART OF A PATIENT, AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508035 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A BUPIVACAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE IN NUMBING THE UPPER BODY PART OF A PATIENT, AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508030 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508005 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE AND GENERAL ANESTHESIA WAS USED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507992 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507925 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507924 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507919 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A LIDOCAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507904 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A LIDOCAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507903 ↗MalfunctionMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE OF THE PORTEX® SPINAL ANESTHESIA TRAY THERE WERE ISSUES WITH THE DRUG LIDOCAINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507899 ↗MalfunctionMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE OF A PORTEX® SPINAL ANESTHESIA TRAY THERE WERE ISSUES WITH THE DRUG LIDOCAINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507896 ↗
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-0245-06 · Nov 17, 2005 · Terminated4950-16 Portex Epidural Mini-pack
- 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-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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