Portex 6947-02Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00351688056071), received between Jun 27, 2019 and Jul 24, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2019Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT THE SLEEVE OF A SMITHS MEDICAL PORTEX® EPIDURAL CATHETER BROKE OFF DURING A PROCEDURE WITH THE PHYSICIAN UNABLE TO EXTRACT IT. SUBSEQUENTLY, FURTHER ATTEMPTS WERE MADE TO ATTEMPT TO REMOVE RETAINED CATHETER SLEEVE WITH NO SUCCESS. THERE WERE NO REPORTED ADVERSE PATIENT COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 8823224 ↗MalfunctionJun 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX DURAFLEX EPIDURAL CATHETER LUER PLUG NEEDLE BROKE OFF INSIDE OF A PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8741527 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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