LeVeen™ Standard M001262130Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729295594), received between Sep 6, 2018 and Mar 9, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2023Failure to Unfold or Unwrap; Defective Device; Therapeutic or Diagnostic Output Failure; Failure to Unfold or Unwrap; Defective Device; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE ARRAY DID NOT DEPLOY PROPERLY, AND INSUFFICIENT ROLL OFF OCCURRED. A 4.0/14/15 LEVEEN STANDARD PROBE WAS SELECTED FOR USE IN A RADIO FREQUENCY ABLATION PROCEDURE IN A METASTATIC LUNG TUMOR. DURING THE PROCEDURE, THE HANDLE OF THE NEEDLE WAS COMPLETELY LOOSE, AND THE PEAK OF THE NEEDLE SLIPPED OUT COMPLETELY WITH MINIMAL FORWARD MOVEMENT. THE NEEDLE WAS STUCK IN THE TUMOR, AND AFTER DEPLOYMENT OF THE ARRAY, THE WHITE PLASTIC END SLIPPED BACK, SO THE NEEDLE WAS NOT COMPLETELY OPEN. TREATMENT WAS PERFORMED WITH TWO CYCLES, BUT THERE WAS NO ROLL OFF. THE NEEDLE WAS NOT EXCHANGED SINCE THERE WERE NO ADDITIONAL NEEDLES AVAILABLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515745 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NEEDLE CAUSED A BURN. A RADIO FREQUENCY ABLATION PROCEDURE WAS BEING PERFORMED ON A TUMOR FOR A PATIENT WITH LIVER CANCER. THE LEVEEN STANDARD WAS BEING USED FOR THIS PROCEDURE. WHEN THE NEEDLE WAS IN POSITION AND THE ABLATION WAS OCCURRING THE NEEDLE WAS HOT AND SMOKING WHICH RESULTED IN THE PATIENT BECOMING BURNED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER THE PROCEDURE, THE PATIENT WAS CONSIDERED STABLE.

  Patient problems: Burn(s)

  MAUDE report 10697370 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED BRADYCARDIA AND A BRIEF PERIOD OF ASYSTOLE. PRELIMINARY ULTRASONOGRAPHY SHOWED A 1.3X1.6 CM HYPOECHOUC NODULE IN HEPATIC SEGMENT VI. THE PATIENT WAS PREPARED IN SUPINE POSITION UNDER ASEPTIC DRAPING AND COMBINED GENERAL-LOCAL ANESTHESIA FOR A RADIOFREQUENCY ABLATION (RFA) PROCEDURE. A 4.0 CM LEVEEN RFA NEEDLE WAS NAVIGATED INTO THE NODULE ULTRASONOGRAPHIC GUIDANCE. ABLATION WAS PERFORMED AND DURING FIRST POSITION OF ABLATION (ABOUT 10 MINS AT ABOUT 170 WATTS) WITH 4.0 DIAMETER OF EXPANSION, THE PATIENT DEVELOPED BRADYCARDIA (HEART RATE FROM 80 BPM TO 30 BPM) AND THEN ASYSTOLE (DURATION ABOUT 2-3 SECONDS) AND SPONTANEOUS RECOVERY. THE EVENTS OF BRADYCARDIA OCCURRED ABOUT 5-6 CYCLES. 0.3 MG OF ATROPINE WAS GIVEN BY ANESTHESIOLOGIST. THEN THE SESSION WAS STOPPED. TOTAL ABLATIVE TIME WAS ABOUT 13 MINUTES. RE-ABLATION WAS DONE AT 130 WATTS AND THE PATIENT DEVELOPED BRADYCARDIA AGAIN. THE SESSION WAS THEN TERMINATED. MILD HYPERECHOIC CHANGE WAS SEEN AND THE TRACT WAS ABLATED. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 7850430 ↗