Teca Elite S53156Recalls & reported problems
Natus Manufacturing Limited · TECA ELITE Disposable Concentric Green Needle, 37mm,.46(26G) diameter, 25 per Pk · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382830017503), received between Dec 14, 2018 and Dec 18, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (3 reports).
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
- Material Separation3
Patient problems
- Not Applicable3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2018Material Separation; Material Separation
HUB SEPARATION NEEDLE ISSUE. DEFECTIVE NEEDLES, THE PLASTIC PROTECTOR IS RELEASED WHEN THE CABLE IS DISCONNECTED AND THE NEEDLE REMAINS CONNECTED TO THE NEEDLE HOLDER. CUSTOMER HAS REPORTED 3 CASES.
Patient problems: Not Applicable
MAUDE report 8173564 ↗MalfunctionDec 18, 2018Material Separation; Material Separation
HUB SEPARATION NEEDLE ISSUE. DEFECTIVE NEEDLES, THE PLASTIC PROTECTOR IS RELEASED WHEN THE CABLE IS DISCONNECTED AND THE NEEDLE REMAINS CONNECTED TO THE NEEDLE HOLDER. CUSTOMER HAS REPORTED 3 CASES.
Patient problems: Not Applicable
MAUDE report 8173502 ↗MalfunctionDec 14, 2018Material Separation; Material Separation
HUB SEPARATION NEEDLE ISSUE. DEFECTIVE NEEDLES, THE PLASTIC PROTECTOR IS RELEASED WHEN THE CABLE IS DISCONNECTED AND THE NEEDLE REMAINS CONNECTED TO THE NEEDLE HOLDER. CUSTOMER HAS REPORTED 3 CASES.
Patient problems: Not Applicable
MAUDE report 8165180 ↗
Other Electrode, Needle, Diagnostic Electromyograph devices
- Technomed Europe TE/S50715-001Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall2 reports
- Technomed Europe TE/S46-638Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall2 reports
- Technomed Europe TE/S50715-001-CTechnomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall0 reports
- Technomed Europe TE/S50715-004Technomed Engineering B.V. · Electrode, Needle, Diagnostic Electromyograph1 recall0 reports
- N/A 8227410Medtronic Xomed, Inc. · Electrode, needle, diagnostic electromyograph12 reports
- Teca Elite S53153Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph7 reports
- Dantec 9013S0032Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph6 reports
- Dantec 9013S0042Natus Manufacturing Limited · Electrode, Needle, Diagnostic Electromyograph4 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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