Skip to content

CHATTANOOGA 2798Recalls & reported problems

Djo, LLC · VECTRA GENISYS 4CH STIM PKG, US STD W/CART · Class 2

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 00888912294768), received between Aug 21, 2019 and Aug 21, 2019 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Full thickness (Third Degree) Burn1
  • Scarring1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE DEVICE FAILED DURING TREATMENT, THEREBY CAUSING THE PATIENT TO SUSTAIN THIRD-DEGREE BURNS AND IRREPARABLE SCARRING OF THE DAMAGED TISSUE. PATIENT HAS REPORTEDLY REQUIRED ONGOING TREATMENT, CARE, AND SURGERY THEREBY ADVERSELY CAUSING INJURIES TO THE PATIENT'S HEALTH, STRENGTH AND ACTIVITY, HAVING SUSTAINED, INTER ALIA, INJURIES TO HER BODY AND OTHER INJURIES. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Patient problems: Full thickness (Third Degree) Burn; Scarring

    MAUDE report 8917026 ↗

Other STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT devices

All STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.