Portex 49662-25Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00351688051311), received between May 11, 2018 and May 11, 2018 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Defective Device” (9 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Device9
Patient problems
- No Consequences Or Impact To Patient9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MARCAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508194 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MARCAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE FOR PAIN BLOCK. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508187 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MARCAINE 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 7508185 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MARCAINE 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 7508183 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MARCAINE MEDICATION IN PORTEX® SPINAL KITS WAS INEFFECTIVE FOR PAIN BLOCK. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508181 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MARCAINE 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 7508171 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT A MARCAINE 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 7508168 ↗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 7507897 ↗MalfunctionMay 11, 2018Defective Device; Defective Device
IT WAS REPORTED THAT THE BUPIVACAINE INSIDE THE PORTEX® SPINAL ANESTHESIA TRAY WAS NOT WORKING. THE DRUG SEEMED TO BE WEARING OFF VERY QUICKLY. THERE WERE NO ALLEGATIONS OF MALFUNCTION WITH RESPECT TO THE OTHER COMPONENTS OF THE KIT. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507695 ↗
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-0242-06 · Nov 17, 2005 · Terminated4902 Glass L.O.R. Syringe
- 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-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 Luer-Lok, BD Glaspak 405609Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
- BD Luer-Lok, BD Glaspak 405735Becton, Dickinson And Company · Anesthesia conduction kit1 recall3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.