Teca Elite S53153Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382830017480), received between Aug 3, 2018 and Dec 10, 2024 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Material Separation; Material Separation

  PART S53153, CONCENTRIC NEEDLES. THE CUSTOMER STATED: A COUPLE OF WEEKS AGO, WE HAD A NEEDLE BREAK AT THE HUB THOUGH WAS ABLE TO RETRIEVE IT FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898342 ↗
• MalfunctionDec 10, 2024Material Separation; Material Separation

  PART: S53153, CONCENTRIC NEEDLES. THE CUSTOMER STATED: THE NEEDLE DISCONNECTED FROM THE HUB AND WE WERE UNABLE TO RETRIEVE IT FROM THE PATIENT'S LEG MUSCLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897564 ↗
• InjuryOct 30, 2018Biocompatibility; Biocompatibility

  PART NUMBER: S53153, LOT# 04B/18/T: PATIENT COMPLAINED OF A SKIN LESION APPEARING AFTER EMG TEST / PROCEDURE WITH A NEEDLE. MESSAGE FROM THE DOCTOR STATED: "PATIENT'S DAUGHTER CALLED TO LET US KNOW THAT THE PATIENT HAD DEVELOPED A SKIN LESION IN HER LEFT CALF AFTER THE EMG ON THE (B)(6) 2018. SHE SENT US A PICTURE THAT LOOKS LIKE A BURN MARK. THERE WAS NO DRAINAGE OR SWELLING. SHE DENIED FEVERS. IT'S PROBABLY DUE TO THE NEEDLE EXAM BUT I HAVE NEVER SEEN A LESION LIKE THAT. OUR NEEDLES ARE STERILE AND SEALED AND I ALWAYS CAREFULLY CLEANSE THE SKIN WITH ALCOHOL SWABS".

  Patient problems: Injury

  MAUDE report 8018495 ↗
• MalfunctionSep 21, 2018Material Separation; Material Separation

  TECA CONCENTRIC NEEDLE HUB TO COLOUR SEPARATION. TECA CONCENTRIC S53153 (1 BOX), RED CASING AROUND THE NEEDLE IS COMING OFF ON EVERY SINGLE NEEDLE ON THIS BOX.

  Patient problems: Not Applicable

  MAUDE report 7897219 ↗
• MalfunctionSep 17, 2018Material Separation; Material Separation

  HUB AND CANNULA SEPARATION FORM COLOUR COVER. S53153, LOT NUMBER 49C/17/T HUB SEPARATION. CUSTOMER HAD THE PLASTIC HUB DETACH FROM THE NEEDLE DURING THE DISCONNECTION FROM THE CABLE.

  Patient problems: Not Applicable

  MAUDE report 7880677 ↗
• MalfunctionSep 17, 2018Material Separation; Material Separation

  HUB AND CANNULA SEPARATION FROM COLOUR COVER. THE S53153, LOT NUMBER 49C/17/T HUB SEPARATION. CUSTOMER HAD THE PLASTIC HUB DETACH FROM THE NEEDLE DURING THE DISCONNECTION FROM THE CABLE.

  Patient problems: Not Applicable

  MAUDE report 7880508 ↗
• MalfunctionAug 3, 2018Material Separation; Material Separation

  HUB AND CANNULA SEPARATION FROM COLOUR COVER. A RED EMG NEEDLE CAME OUT OF ITS PROTECTIVE CYLINDER WHILE PERFORMING AN EMG, THE NEEDLE CAME LOOSE FROM THE RED HOUSING ON THE S53153 TECA CONCENTRIC NEEDLE.

  Patient problems: Not Applicable

  MAUDE report 7746082 ↗