LeVeen™ SuperSlim™ M001262270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729441700), received between Jun 10, 2021 and Dec 4, 2024 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAUTERINE FETAL DEATH OCCURRED. A 2.0CM X 25CM LEVEEN SUPERSLIM NEEDLE ELECTRODE WAS SELECTED FOR USE WITH AN RF 3000 GENERATOR. RADIOFREQUENCY ABLATION (RFA) WAS PERFORMED IN A TWIN REVERSED ARTERIAL PERFUSION (TRAP) PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED UNDER ULTRASOUND, AND AFTER 25 CUMULATIVE MINUTES, THERE WAS ROLL OFF WITH AN IMPEDANCE OF 270OHM. PROCEDURALLY, THE PHYSICIAN DEEMED THE CASE A SUCCESS. THERE WERE NO DEVICE ISSUES. EVERYTHING PROCEDURALLY WAS AS EXPECTED. HOWEVER, A SLIGHTLY DECREASED HEARTBEAT OF THE PUMP TWIN (INTENDED SURVIVING TWIN) WAS NOTED BY THE END OF THE PROCEDURE. THE DECREASED HEARTBEAT WAS A CONSEQUENCE OF HEMODYNAMIC CHANGES IN RESPONSE TO RFA. IT WAS REPORTED THAT THE POSSIBILITY OF THIS OCCURRING WAS DISCUSSED WITH THE PATIENT. SUBSEQUENTLY, THE PUMP TWIN WAS UNWELL TO THE POINT OF BEING NON-VIABLE/DECEASED. THE MOTHER WAS WELL.

  Patient problems: Bradycardia

  MAUDE report 20844967 ↗
• MalfunctionJun 10, 2021Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THERE WAS SEVERE RESISTANCE. A 2.0/17/25 LEVEEN NEEDLE ELECTRODE WAS SELECTED FOR USE TO TREAT LIVER CANCER. AFTER PUNCTURE WITH THE NEEDLE, THERE WAS SEVERE RESISTANCE WHILE ADVANCING. USAGE WAS DISCONTINUED. A DIFFERENT DEVICE WAS SELECTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979318 ↗