Portex 3717C-20Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00351688062898), received between May 23, 2016 and May 11, 2018 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information4
- Adverse Event Without Identified Device or Use Problem1
- Missing Value Reason1
Patient problems
- No Consequences Or Impact To Patient5
- Awareness During Anesthesia1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE OF THE PORTEX® SPINAL ANESTHESIA TRAY BUPIVACAINE FAILED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508052 ↗MalfunctionMay 11, 2018Missing Value Reason; Missing Value Reason
IT WAS REPORTED THAT DURING USE OF THE PORTEX® SPINAL ANESTHESIA TRAY BUPIVACAINE FAILED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508042 ↗MalfunctionMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE OF THE PORTEX® SPINAL ANESTHESIA TRAY BUPIVACAINE FAILED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507994 ↗MalfunctionMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE OF THE PORTEX® SPINAL ANESTHESIA TRAY BUPIVACAINE FAILED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507966 ↗MalfunctionMay 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING USE OF THE PORTEX® SPINAL ANESTHESIA TRAY BUPIVACAINE FAILED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7507958 ↗InjuryMay 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
USER FACILITY REPORTED THAT THE DEVICE WAS PLACED IN USE WITH PATIENT FOR SPINAL ANESTHESIA BUT THE DRUG DID NOT TAKE EFFECT. ACCORDING TO REPORTER, THE PROCEDURE REQUIRED GENERAL ANESTHESIA DUE TO THIS ISSUE. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.
Patient problems: Awareness During Anesthesia
MAUDE report 5674115 ↗
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-0245-06 · Nov 17, 2005 · Terminated4950-16 Portex Epidural Mini-pack
- 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-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.