Kainox VCS 60 124325Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04035479011987), received between Dec 3, 2020 and May 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2022Break; Break

  LEAD WAS EXPLANTED BECAUSE IT WAS FOUND TO BE SEVERED DURING A FOLLOW-UP APPOINTMENT. UPON EXTRACTION, THE LEAD WAS FOUND TO BE BROKEN IN HALF. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14380261 ↗
• MalfunctionOct 8, 2021Fracture; Fracture

  THIS PREVIOUSLY ABANDONED LEAD WAS ATTEMPTED TO BE EXTRACTED DUE TO A FRACTURE, HOWEVER WAS UNSUCCESSFUL. PART WAS REMOVED AND PART REMAINS IN THE PATIENT. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12600618 ↗
• MalfunctionDec 3, 2020Fracture; Fracture

  IT WAS REPORTED THAT IN (B)(6) 2020 THE PATIENT WAS IN THE HOSPITAL FOR SHOULDER PAIN (UNRELATED TO ICD SYSTEM). IT WAS DISCOVERED THAT THE LEAD COIL WAS FRACTURED BUT THE LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10942679 ↗