NanoKnife 20300301USRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI H78720300301US0), received between Jan 31, 2024 and Mar 4, 2026 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K183385); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Computer Software Problem

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NANOKNIFE 3.0 GENERATOR. DURING AN IRE PROCEDURE, A "HARDWARE COMMUNICATION ERROR" OCCURRED. THE UNIT HAD BEEN TURNED ON FOR 10-15 MINUTES AND THEN TURNED OFF. WHEN IT WAS TURNED BACK ON, IT THREW THE CODE IMMEDIATELY AND WOULD NOT START UP AGAIN. NO TREATMENT HAD BEEN PROVIDED TO THE PATIENT. THE PROCEDURE WAS ABORTED AND THE PATIENT, UNDER GENERAL ANESTHESIA, HAD TO BE WOKEN UP. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512162 ↗
• MalfunctionJul 1, 2025Failure of Device to Self-Test; Failure of Device to Self-Test

  A CLINICAL SPECIALIST REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NANOKNIFE 3.0 GENERATOR. THE TREATING PHYSICIAN REPORTED THAT HE WAS IN THE OR AND HAD A PATIENT READY TO TREAT BUT WAS GETTING AN ERROR "DISK READ ERROR OCCURRED" DURING THE SELF TEST STEP. THE PATIENT WAS SEDATED UNDER GENERAL ANESTHESIA AND NO PULSES WERE DELIVERED. DUE TO THIS EVENT, THE PROCEDURE WAS ABORTED AND A SECOND PROCEDURE WAS SCHEDULED FOR (B)(6) 2025 WITH ANOTHER NK UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371691 ↗
• MalfunctionJun 23, 2025Smoking; Smoking

  AN END USER REPORTED AN ISSUE WITH A NANOKNIFE 3.0 GENERATOR. DURING A ROUTINE ELECTRICAL TEST OF THE UNIT, WHEN THE UNIT WAS TURNED ON, A NOISE WAS HEARD AND SMOKE CAME OUT OF THE AIR VENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308172 ↗
• MalfunctionFeb 4, 2025Device Emits Odor; Device Emits Odor

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NANOKNIFE 3.0 GENERATOR. BEFORE THE UNIT WAS TURNED ON FOR THE PROCEDURE, THE PATIENT WAS INTUBATED. THEY THEN TRIED TO BOOT UP THE UNIT IN THE OR ROOM, BUT THE SYSTEM WAS DOWN. THEY THEN SMELLED A STRONG SMOKING, BURNING ODOR. THE PROCEDURE WAS NOT CONTINUED DUE TO THIS EVENT. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE DUE TO PATIENT SAFETY RISK, AS THE PATIENT WAS UNDER ANESTHESIA AND TREATMENT WAS NOT COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304097 ↗
• MalfunctionFeb 4, 2025Computer Software Problem; Computer Software Problem

  ADSDITIOANL INFORMATION: THE TOUCHSCREEN WAS NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304096 ↗
• MalfunctionOct 22, 2024Power Problem; Power Problem

  AN ANGIODYNAMICS SENIOR REGIONAL BUSINESS MANAGER REPORTED AN ISSUE WITH A NANOKNIFE 3.0 GENERATOR. THE UNIT IS NOT WORKING, IT ACTS AS THE RED BUTTON (EMERGENCY) IS ON. THE NK GENERATOR DIDN'T WANT TO START. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME AND NOT TREATED. THE PROCEDURE NEEDED TO BE POSTPONE UNTIL FORMEDICAL ARRIVED TO CHECK THE EQUIPMENT. THE UNIT WAS REPAIRED AND THE PATIENT WAS BROUGHT BACK IN FOR TREATMENT THAT NIGHT. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THIS EVENT MEETS THE CRITERIA A REPORTABLE ADVERSE EVENT; PATIENT SAFETY RISK AS TREATMENT WAS NOT PROVIDED, BUT PATIENT HAD BEEN SEDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509296 ↗
• DeathJul 15, 2024Communication or Transmission Problem; Failure of Device to Self-Test; Communication or Transmission Problem; Failure of Device to Self-Test

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A NANOKNIFE 3.0 GENERATOR. DURING TREATMENT, WHEN USING THE LAST PAIR OF PROBES, THE UNIT DISPLAYED AND "OUT OF ORDER" MESSAGE, MESSAGE 2048. DUE TO THIS, THE PROCEDURE WAS NOT COMPLETED. IT WAS ALSO REPORTED A HARDWARE/COMMUNICATION ERROR OCCURRED. ADDITIONAL INFORMATION: THE NK WAS BLOCKED DURING THE TREATMENT. AFTER THEY TRY AROUND 10 TIME TO START AGAIN THE NK. THE ERROR 2048 IS STILL ON THE NK. I HAVE CHECK THIS 2 TIMES, ERROR 2048 IS STILL ON THE NK. AFTER PUT THE ECG ON THE ONE NK I BRING, I TRY AGAIN THE "ANGERS" NK. THIS TIME, HE WILL START PROPERLY. I TRY TO CONNECT BACK THE ECG AND IT STILL START PROPERLY. ADDITIONAL INFORMATION PROVIDED JULY 05, 22024: PATIENT HAS EXPIRED. THIS OCCURRED IN THE ICU 24 HOURS AFTER THE PROCEDURE. IT WAS REPORTED BY ONE OF THE DOCTORS THAT THE PATIENT DIED IN THE EARLY MORNING BECAUSE OF ARRHYTHMIA AND LIVER FAILURE. THE CARDIOLOGIST DISAGREED SAYING THE PATIENT DID NOT HAVE ARRHYTHMIA AND ANOTHER DOCTOR CONCLUDED THE PATIENT DIED OF SEPSIS.

  Patient problems: Arrhythmia; Sepsis

  MAUDE report 19744605 ↗
• MalfunctionJan 31, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  DURING SELF-TEST, THE NANOKNIFE 3.0 GENERATOR UNIT DISPLAYED "FAILED TO LOCATE NANOKNIFE CONTROLLER" ERROR MESSAGE. THE END USER HAD PLACED THE PATIENT UNDER GA PRIOR TO TURNING ON THE NANOKNIFE GENERATOR. SINCE CASE WAS ABORTED AND NO TREATMENT PROVIDED TO PATIENT THIS EVENT MEETS THE CRITERIA OF REPORTABILITY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18615095 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183385. One submission often covers many models, so check the product and lot details in each record.

• Z-1381-2023 · Mar 2, 2023 · Open, Classified
  NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110