EchoTuohy Epidural Needle E6-2150-17Recalls & reported problems
Hakko CO.,Ltd. · 17G x 6"(152mm) Plastic hub, with wings Calibrations & Echogenic Tip. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04526737171098), received between Apr 19, 2018 and Apr 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Patient-Device Incompatibility1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2018Fracture; Patient-Device Incompatibility; Fracture; Patient-Device Incompatibility
DESCRIBE THE EVENT OR PROBLEM: PATIENT WAS PLACED INTO STANDARD SEATED POSITION FOR EPIDURAL PLACEMENT. ANATOMICAL LANDMARKS WERE ATTEMPTED TO BE ISOLATED, HOWEVER DUE TO PATIENT'S BODY HABITUS, NEITHER PELVIC BRIM, NOR INDIVIDUAL SPINOUS PROCESS COULD BE PALPATED. A WIDE AREA IN THE PRESUMED L3/4 AREA WAS CLEANED USING STANDARD CHLORAPREP TECHNIQUE AND A STERILE DRAPE WAS APPLIED. THE PLANNED AREA FOR NEEDLE INSERTION WAS SUBCUTANEOUSLY INJECTED WITH 3ML OF 1% LIDOCAINE AND AN INITIAL ATTEMPT WAS MADE WITH THE STANDARD TUOHY NEEDLE (17G,11CM LONG) AVAILABLE IN THE EPIDURAL KIT. THE NEEDLE WAS ADVANCED TO THE HUB WITHOUT LOSS OF RESISTANCE AND I DECIDED TO USE A LONGER TUOHY NEEDLE, A 15CM, 17G TUOHY NEEDLE WAS ADVANCED AND AN INITIAL LOSS OF RESISTANCE WAS FELT AT THE 11 CM MARK. THE CATHETER WAS THREADED; HOWEVER, BLOOD WAS NOTED TO RETURN THROUGH THE CATHETER SO IT WAS REMOVED AND THE NEEDLE WAS PULLED BACK. THE INTRODUCER WAS REPLACED AND A SECOND PASS WITH THE LONG NEEDLE WAS ATTEMPTED. ONCE AGAIN, NO LOSS OF RESISTANCE WAS NOTED. THERE HAD BEEN SOME INCREASED RESISTANCE TO NEEDLE ADVANCEMENT, HOWEVER, IT WAS NO MORE THAN HAD BEEN EXPERIENCED DURING PREVIOUS EPIDURAL PLACEMENT
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7445861 ↗
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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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