NanoKnife 20300101Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787203001010), received between Mar 3, 2021 and Mar 26, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (1 report).

1 other recall cover devices cleared under the same FDA submission (K150089); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Failure to Deliver Energy; Failure to Deliver Energy

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A NANOKNIFE 2.2 GENERATOR. AT THE START OF THE PROCEDURE, THE PATIENT WAS SEDATED AND THE NEEDLE WAS PLACED. WHEN ATTEMPTING TO START APPLYING ENERGY BY STEPPING ON THE FOOT PEDAL, THE SYSTEM WAS NOT ABLE TO RECOGNIZE THE FOOT PEDAL, SO THEY WERE NOT ABLE TO DELIVER THE ENERGY. THEY THOUGHT IT WAS POSSIBLY DUE TO THE FOOT PEDAL WAS NO LONGER FUNCTIONING OR THE FOOT PEDAL CONNECTOR INTO THE GENERATOR WAS NOT FUNCTIONING. THE PROCEDURE WAS UNABLE TO BE PERFORMED AND THEREFORE ABORTED. 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 21700168 ↗
• MalfunctionMay 30, 2024Unexpected Shutdown; Unexpected Shutdown

  DURING THE MIDDLE OF AN IRE CASE, THE NANOKNIFE GENERATOR SHOWED A HIGH CURRENT AND AUTOMATICALLY TURNED OFF. DURING THE PATIENT'S FOLLOW UP APPOUINTMENT A FEW WEEKS POST PROCEDURE, IT WAS REPORTED THE PATIENT HAD A RECTAL FISTULA AND THERE COULD BE SOME THERMAL DAMAGETHOUGHT TO BE CAUSED BY THE NANOKNIFE UNIT ISSUES. ULTIMATELY, THE PATIENT REQUIRED SURGERY TO TREAT THE 3MM FISTULA, LOCATED NEAR RECTUM-TREATMENT AREA MID-PROSTATE. THE PATIENT WAS REPORTED AS CURRENTLY STABLE AND RECOVERING.

  Patient problems: Fistula

  MAUDE report 19423453 ↗
• MalfunctionFeb 20, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  WHILE PERFORMING A PROSTATE CASE WITH A NANOKNIFE GENERATOR. WHEN DELIVERING THE TEST PULSE, THE CHARGE SECTION COULD NOT CHARGE UP AND A WARNING MESSAGE (FAILURE TO CHARGE UP ) CAME OUT THEN HARDWARE COMMUNICATION ERROR . THEY PRESSED "OK", AND THE MACHINE SHUT DOWN. THEY COULD NOT REBOOT TBHE UNIT DESPITE 6 ATTEMPTS. THE UNIT COULD NOT PASS THE SELF-TEST, AND THE USER ALSO TRIED PRESSING EMERGENCY BUTTON A FEW TIMES. THE OT MANAGER DECIDED TO ABANDON THE PROCEDURE, REMOVED THE PROBE AND DISPOSED OF IT. AT THAT TIME, THEY DID A SEVENTH ATTEMPT TO START THE UNIT, WHICH RESULTED IN THE UNIT REBOOTING AND PASSING THE SELF TEST. THE PROCEDURE WAS RESUMED WITH THREE NEW PROBES. THE PROCEDURE WAS COMPLETED AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE DUE TO PATIENT SAFETY RISK, AS THE PATIENT WAS UNDER ANESTHESIA FOR GREATER THAN 30 MINUTES AS CONSIDERED NORMAL FOR THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741579 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS INTERNATIONAL MEDICAL SCIENCE LIAISON (ONCOLOGY & SURGERY) REPORTED A PATIENT ISSUE, POST NANOKNIFE PROCEDURE. THE PATIENT DEVELOPED A PROSTATE/RECTAL FISTULA AFTER RECEIVING TREATMENT FOR PROSTATE CANCER. THE DOCTOR FEELS THAT THIS IS NOT RELATED TO A DEVICE FAILURE BUT RATHER TO THE PROCEDURE. THE PHYSICIAN PLANNED TO CONTACT PEERS FOR ADVISE REGARDING THE BEST TREATMENT OPTIONS FOR THE PATIENT BUT DOCUMENTED THAT AN ADDITIONAL PROCEDURE(S) WILL BE NEEDED. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT HAS HAD FOLLOW UP SINCE THIS EVENT. HE PRESENTED WITH THIS FISTULA ON (B)(6) 2011. HE REMAINED IN THE HOSPITAL FOR 5 DAYS, WHERE HE RECEIVED A SUPRAPUBIC URINARY CATHETER, WILL THE PATIENT STILL HAS. THE FISTULA WAS SEEN ON A CT SCAN, AND WAS ALSO SEEN BY A CYTOSCOPY. SINCE THAT TIME, THE PATIENT HAS RECEIVED THREE PROSTATE MRI'S TO OBSERVE/FOLLOW THE FISTULA. THE PATIENT HAD PRESENTED WITH PAIN AND WEIGHT LOSS APPROXIMATELY 4 WEEKS AFTER THE INITIAL PROCEDURE. THE PATIENT DESCRIBED THE LOSS OF URINE VIA THE RECTUM WHEN ATTEMPTING TO VOID HIS BADDER. THE IMAGING PERFORMED SHOWED TYPICAL DAMAGE TO THE PROSTATIC TISSUE WITH INVOLVEMENT OF THE RECTUM WALL. THERE

  Patient problems: Fistula

  MAUDE report 11407228 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150089. One submission often covers many models, so check the product and lot details in each record.

• Z-0073-2022 · Apr 24, 2020 · Terminated
  AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103