TruNode Surgical Gamma Probe 120-807605Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15420045512856), received between Sep 12, 2024 and Aug 17, 2026 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50285270 ↗
• MalfunctionAug 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50284716 ↗
• InjuryJun 10, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2026, "THE TRUNODE GAMMA PROBE STARTED MALFUNCTIONING. IT WOULD GIVE ME READINGS OF 9999 RANDOMLY EVEN WHEN THE PROBE WAS DIRECTED AWAY FROM THE PRIMARY INJECTION SITE TOWARDS THE WALL. ALSO, THE SENTINEL LYMPH NODE BASIN WOULD GIVE VERY LOW READINGS IN THE TEENS AND TWENTIES WITH NO AREA OF ¿HOT¿ ACTIVITY, WHICH MADE IDENTIFICATION OF THE SENTINEL LYMPH NODE IMPOSSIBLE. I TRIED REPLACING THE PROBE A COUPLE OF TIMES, AS WELL AS REPLACING THE ASSOCIATED TRUNODE SCREEN/MONITOR, WITHOUT RESOLUTION OF THE ISSUE." CUSTOMER OUTREACH WAS PERFORMED, BUT NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME DUE TO NO RESPONSE. REPORT STATED THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460418 ↗
• MalfunctionSep 5, 2025Therapeutic or Diagnostic Output Failure; Activation Problem

  DISPOSABLE TRUNODE HANDPIECE REF:120-807605 NOT WORKING. HANDPIECE TURNING ON AND TALKING TO TABLET BUT NOT PICKING UP NUCLEAR MEDICINE OVER PATIENT. TRIED NEW TABLET BUT HAD TO CHANGE OUT HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977081 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE FOR DETECTION AND LOCALIZATION OF SENTINEL LYMPH NODES ON A 18-45 YEARS OLD FEMALE WITH BREAST CANCER, A TRUNODE WAS USED. IT WAS REPORTED THAT THE PATIENT EXHIBITED INFECTION SYMPTOMS PERIPROCEDURAL IT WAS REPORTED THAT THE PATIENT RECEIVED ORAL MEDICATION FOR TREATMENT AND PROLONGED HOSPITALIZATION. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 21405965 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER A TRUNODE PROCEDURE WHICH WAS RELATED TO HEAD AND NECK CANCER, THE PATIENT PRESENTED WITH INFECTION WHICH REQUIRED INTRAVENOUS MEDICATION AND THAT THE INFECTION HAD RESOLVED. MULTIPLE ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION WERE NOT RESPONDED. NO OTHER INFORMATION RECEIVED.

  Patient problems: Bacterial Infection

  MAUDE report 21405618 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE FOR DETECTION AND LOCALIZATION OF SENTINEL LYMPH NODES ON A 31-45 YEAR OLD MALE WITH MELANOMA, A TRUNODE WAS USED. IT WAS REPORTED THAT THE PATIENT EXHIBITED INFECTION SYMPTOMS AROUND 8-14 DAYS AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED ORAL MEDICATION FOR TREATMENT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 21404463 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER A TRUNODE PROCEDURE WHICH WAS RELATED TO BREAST CANCER, THE PATIENT PRESENTED WITH INFECTION WHICH REQUIRED ORAL MEDICATION AND THAT THE INFECTION HAD RESOLVED. MULTIPLE ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION WERE NOT RESPONDED. NO OTHER INFORMATION RECEIVED.

  Patient problems: Bacterial Infection

  MAUDE report 21403095 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, AFTER A TRUNODE PROCEDURE WHICH WAS RELATED TO COLON CANCER, THE PATIENT PRESENTED WITH INFECTION WHICH REQUIRED ORAL MEDICATION AND THAT THE INFECTION WAS IMPROVING. IT WAS REPORTED THAT THERE WAS A CROSS-CONTAMINATION DUE TO THE REUSE OF THE TRUNODE GAMMA PROBE. MULTIPLE ATTEMPTS AT OBTAINING ADDITIONAL INFORMATION WERE NOT RESPONDED. NO OTHER INFORMATION RECEIVED.

  Patient problems: Bacterial Infection

  MAUDE report 21401274 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A TRUNODE PROCEDURE ON (B)(6) 2023, 3 DAYS LATER IT WAS REPORTED THAT THE PATIENT EXHIBITED INFECTION SYMPTOMS WITH FEVER AND HIGH WHITE CELL COUNT. FOR THIS THE PATIENT WAS PRESCRIBED AMOXICILLIN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 21131810 ↗
• MalfunctionSep 12, 2024

  OVER 60-YEAR-OLD FEMALE WITH RECENT HISTORY OF BREAST CANCER. PROCEDURE: LEFT BREAST REFLECTOR LOCALIZED LUMPECTOMY WITH SENTINEL LYMPH NODE BIOPSY, POSSIBLE AXILLARY DISSECTION. TRINODE PROBE WOULD NOT CALIBRATE WITH UNIT. ANOTHER PROBE USED SUCCESSFULLY. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR PROBE, UPTAKE, NUCLEAR, TRUNODE SURGICAL GAMMA PROBE (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: Breast Cancer; Nodule

  MAUDE report 20199440 ↗