Dantec 9013S0042Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05704736002882), received between Jul 18, 2019 and Apr 22, 2022 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 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 14183870 ↗
• InjuryJul 18, 2019Material Separation; Material Separation

  HUB TO COLOUR COVER SEPARATION INCIDENT. THE CUSTOMER NOTED THAT THERE WERE 3 INCIDENTS WITH THESE NEEDLES AND IN ONE INCIDENT (1-620443305), A PHYSICIAN RECEIVED A NEEDLE STICK. THERE HAS BEEN 3 COMPLAINTS OPENED TO DOCUMENT AND REPORT ALL 3 ISSUES: (B)(4) (3005581270-2019-00009). (B)(4) (3005581270-2019-00010). (B)(4).

  Patient problems: Needle Stick/Puncture

  MAUDE report 8801571 ↗
• InjuryJul 18, 2019Material Separation; Material Separation

  HUB TO COLOUR COVER SEPARATION INCIDENT. THE CUSTOMER NOTED THAT THERE WERE 3 INCIDENTS WITH THESE NEEDLES AND IN ONE INCIDENT (B)(4), A PHYSICIAN RECEIVED A NEEDLE STICK. THERE HAS BEEN 3 COMPLAINTS OPENED TO DOCUMENT AND REPORT ALL 3 ISSUES: (B)(4) (3005581270-2019-00009), (B)(4), (B)(4) (3005581270-2019-00011).

  Patient problems: Needle Stick/Puncture

  MAUDE report 8801568 ↗
• InjuryJul 18, 2019Material Separation; Material Separation

  HUB TO COLOUR COVER SEPARATION INCIDENT. WHEN DISENGAGING THE NEEDLE FROM THE CABLE, THE PLASTIC PART OF THE NEEDLE RELEASED IN THE PHYSICIANS HAND AND THE NEEDLE REMAINED CONNECTED TO THE CABLE, THIS RESULTED IN AN EMPLOYEE INCIDENT WHERE A PHYSICIAN RECEIVED A NEEDLE STICK. THE CUSTOMER NOTED THAT THERE WERE 3 INCIDENTS WITH THESE NEEDLES AND IN ONE INCIDENT ((B)(4)), A PHYSICIAN RECEIVED A NEEDLE STICK. THERE HAS BEEN 3 COMPLAINTS OPENED TO DOCUMENT AND REPORT ALL 3 ISSUES: (B)(4) (THIS AE NO.), (B)(4) (AE NO. 3005581270-2019-00010), (B)(4) (AE NO. 3005581270-2019-00011).

  Patient problems: Needle Stick/Puncture

  MAUDE report 8801566 ↗