Dantec 9013S0032Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05704736002875), received between Mar 16, 2018 and Apr 22, 2022 — classified as 1 injury, 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2022Material Twisted/Bent; Material Twisted/Bent

  ON SEVERAL DIFFERENT PATIENTS, DURING VOLUNTARY CONTRACTION (MAINLY ILIOPSOAS, QUADRICEPS AND MEDIAL GASTROCNEMIUS MUSCLES), THE NEEDLES USED WERE TWISTED. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14184310 ↗
• MalfunctionApr 22, 2022Material Twisted/Bent; Material Twisted/Bent

  THE NEEDLE BENDS, TWISTS AND DOES NOT PENETRATE THE PATIENT'S MUSCLE. THIS CAUSES PAIN. THE NEEDLE DOES NOT BREAK. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14183735 ↗
• MalfunctionOct 7, 2019Material Separation; Material Separation

  THE CONSULTANT REPORTS THAT HE HAS HAD A COUPLE OF EPISODES OF TRYING TO REMOVE THE EMG NEEDLE FROM THE EMG HOLDER CABLE AT THE END OF THE TEST, ONLY TO FIND THAT THE ENTIRE PLASTIC SURROUND (INCLUDING THE COLOURED PLASTIC) HAS COME OFF BUT THE NEEDLE ITSELF REMAINS IN THE HOLDER. AS HE WOULD NOT BE EXPECTING THIS TO HAPPEN HE WAS CONCERNED ABOUT NEEDLE STICK INJURIES. THE DEPARTMENT HAVE KEPT THE BATCH NUMBERS FOR REFERENCE.

  Patient problems: Not Applicable

  MAUDE report 9160583 ↗
• MalfunctionAug 15, 2018Material Separation; Material Separation

  HUB AND CANNULA SEPARATION FROM COLOUR COVER DURING REMOVAL OF CONNECTOR CABLE. "WHEN PULLING OUT THE EMG NEEDLE, THE PLASTIC SOCKET WILL DETACH AT THE CONNECTION OF EMG NEEDLE TO LEAD CABLE, THEREBY UNCONTROLLABLE NEEDLE MOVEMENT AND RISK OF INJURY TO USERS."

  Patient problems: Not Applicable

  MAUDE report 7784042 ↗
• MalfunctionApr 16, 2018Detachment Of Device Component; Material Separation; Detachment Of Device Component; Material Separation

  HUB AND CANNULA SEPARATION FROM THE COLOUR COVER. WHEN PULLING OUT THE EMG NEEDLE FROM THE CABLE, THE COLOUR COVER OF THE NEEDLE DETACHED RESULTING IN UNCONTROLLABLE NEEDLE MOVEMENT AND RISK OF INJURY TO USERS.

  Patient problems: Not Applicable

  MAUDE report 7432641 ↗
• InjuryMar 16, 2018Detachment Of Device Component; Detachment Of Device Component

  PART NUMBER: 9013S0032 DANTEC CONCENTRIC NEEDLE, LOT: 44B/17/D - NEEDLE DISENGAGED AND THE DOCTOR WAS HURT. IN TRYING TO DISCONNECT THE EMG NEEDLE FROM THE CABLE WITH THE THUMB AND INDEX FINGER, THE PLASTIC OF THE COVER ASSEMBLY SLIPPED OVER THE SOLID PARTS OF THE NEEDLE CRANIALLY, THEREBY A STITCH IN THE THUMB OCCURRED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 7345106 ↗