NanoKnifeRecalls & reported problems across all models

We found 9 models of NanoKnife by Angiodynamics, Inc. in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Oct 11, 2016 and Mar 4, 2026 — classified as 1 death, 23 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (6 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

NanoKnife recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 2, 2023Open, Classified

   Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure

   Z-1381-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported NanoKnife problems

NanoKnife models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• NanoKnife H787204001110

  Low energy direct current thermal ablation system
  1 recall0 reports
• NanoKnife 20400107

  Low energy direct current thermal ablation system
  10 reports
• NanoKnife 20300301US

  Low energy direct current thermal ablation system
  1 death8 reports
• NanoKnife 20400103

  Low energy direct current thermal ablation system
  8 reports
• NanoKnife 20400104

  Low energy direct current thermal ablation system
  6 reports
• NanoKnife 20300101

  Low energy direct current thermal ablation system
  4 reports
• NanoKnife 20400111

  Low energy direct current thermal ablation system
  4 reports
• NanoKnife 20400109

  Low energy direct current thermal ablation system
  3 reports
• NanoKnife 20400101

  Low energy direct current thermal ablation system
  1 report

Recent NanoKnife adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryOct 27, 2025Use of Device Problem; Use of Device Problem

  PATIENT INJURY: A TERRITORY MANAGER, IN ATTENDANCE FOR THE CASE, REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING 5-PROBE PROCEDURE PACK-ACTIVATION, 15CM. THE FIRST TWO PROBES WERE USED WITH NO REPORTED ISSUES. DURING THE THIRD PROBE PLACEMENT, THE PHYSICIAN PUNCTURED THE PATIENT'S BLADDER AND POPPED THE FOLEY CATHETER BALLOON. THE FOLEY WAS REPLACED AND THE PROCEDURE WAS CONTINUED. WHEN THE FOURTH PROBE WAS PLACED, THE DOCTOR STUCK HIS FINGER CAUSING HIS FINGER TO BLEED. BEFORE THE TM WAS ABLE TO INTERVENE, THE PHYSICIAN INSERTED THE CONTAMINATED 4TH PROBE INTO THE PATIENT AND CONTINUED THE PROCEDURE. IT WAS REPORTED HE DID CHANGE HIS GLOVES AFTER 3-5 MINUTES OF PUNCTURING HIS FINGER. THE PROCEDURE WAS COMPLETED WITH THE FOURTH PROBE.

  Patient problems: Internal Organ Perforation; Perforation

  MAUDE report 23391568 ↗
• InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN INJURY: A TERRITORY MANAGER, IN ATTENDANCE FOR THE CASE, REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING 5-PROBE PROCEDURE PACK-ACTIVATION, 15CM. THE FIRST TWO PROBES WERE USED WITH NO REPORTED ISSUES. DURING THE THIRD PROBE PLACEMENT, THE PHYSICIAN PUNCTURED THE PATIENT'S BLADDER AND POPPED THE FOLEY CATHETER BALLOON. THE FOLEY WAS REPLACED AND THE PROCEDURE WAS CONTINUED. WHEN THE FOURTH PROBE WAS PLACED, THE DOCTOR STUCK HIS FINGER CAUSING HIS FINGER TO BLEED. BEFORE THE TM WAS ABLE TO INTERVENE, THE PHYSICIAN INSERTED THE CONTAMINATED 4TH PROBE INTO THE PATIENT AND CONTINUED THE PROCEDURE. IT WAS REPORTED HE DID CHANGE HIS GLOVES AFTER 3-5 MINUTES OF PUNCTURING HIS FINGER. THE PROCEDURE WAS COMPLETED WITH THE FOURTH PROBE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23391556 ↗
• MalfunctionSep 17, 2025Arcing; Arcing

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH A 15 CM IRE SINGLE ACTIVATION ELECTRODE. DURING THE 3RD ABLATION OF A DESMOID TREATMENT, ONE PROBE STARTED ARCING, PAST THE SKIN, WHILE STILL INSERTED IN THE PATIENT. THE PREVIOUS 2 ABLATIONS DONE WITH THIS DEVICE WERE SUCCESSFUL WITH NO ISSUES. THIS ONLY OCCURRED WHILE THAT PROBE WAS IN ACTIVE USE, AND WAS QUICKLY SHUT DOWN AFTER JUST A FEW PULSES. THE PHYSICIAN THEN REMOVED THAT PROBE AND COMPLETED THE ABLATION WITH THE UNAFFECTED PROBES. 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 23076478 ↗
• 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 ↗
• MalfunctionApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A 15 CM IRE SINGLE ELECTRODE RFID ACTIVATION PROBE. THE PATIENT PRESENTED ON (B)(6) 2025 FOR A NANOKNIFE PROSTATE TREATMENT. BILATERAL APEX 6 ELECTRODES IN TREATMENT NAÏVE GLAND. CAUTION AND CARE WAS TAKEN TO AVOID RECTAL ABLATION. THE DOCTOR REPORTED A SUSPECTED URETHRORECTAL FISTULA AND SENT THE PATIENT TO THE ER. HE SUSPECTED IT WAS FROM THE IN AND OUT CATHETERIZATION REQUIRED. A CATHETER WAS LEFT IN FOR 9 DAYS POST PROCEDURE DUE TO PATIENT HAVING CONSTIPATION. FAILED FIRST DISCONTINUATION ATTEMPT OF URINARY CATHETER. THE CATHETER WAS LEFT IN FOR ONE MORE WEEK. FAILED DISCONTINUATION AGAIN. THE PATIENT STARTED IN AND OUT SELF-CATHETERIZATION ON FRIDAY ON (B)(6) 2025. ON (B)(6) 2025, THE DOCTOR WAS NOTIFIED OF URINE PASSING OUT OF RECTUM. ON (B)(6) 2025, THE DOCTOR SCOPED THE PATIENT FOR A VISUAL ASSESSMENT. THE DOCTOR CONCLUDED THE IN AND OUT CATHETER UNDERMINED THE PROSTATE AND CREATED A HOLE. ON RECTAL EXAM THE CATHETER CANNOT BE FELT OR PALPATED. THE CATHETER WILL BE LEFT IN FOR 6 WEEKS THEN ANOTHER REASSESSMENT WILL BE PERFORMED.

  Patient problems: Fistula

  MAUDE report 21884440 ↗
• 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 ↗
• 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 ↗
• MalfunctionNov 13, 2024Arcing of Electrodes; Arcing of Electrodes

  DEVICE 2 OF 3: A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING THREE 15 CM IRE SINGLE ELECTRODE RFID ACTIVATION PROBES. PLACEMENT OF NANOKNIFE PROBES USING SURGICAL METAL CLAMPS TO FACILITATE MANIPULATION UNDER SCANNER CONTROL. DURING TREATMENT, ELECTRIC ARCS APPEAR ON THE PATIENT'S SKIN ON 3 DIFFERENT PROBES. EMERGENCY STOP OF THE PROCEDURE THEN REPLACEMENT OF THE PROBES WITH NEW ONES (WITHOUT MANIPULATION BY METAL CLAMPS). CORRECT TREATMENT, NO COMPLICATIONS OR HARM TO THE PATIENT. TREATMENT COMPLIANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673393 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL AFFAIRS DIRECTOR REPORTED AN END USER EXPERIENCED AN ADVERSE EVENT POST PROCEDURE IN WHICH A NANOKNIFE SYSTEM WAS USED. AS REPORTED: RIGHT POSTERIOR PERIPHERAL ZONE LESION ABLATED WITH 5 IRE ELECTRODES. 3 WEEKS LATER PATIENT PRESENTS WITH DYSURIA AND URINE LEAKING FROM RECTUM DURING URINATION. CYSTOSCOPE COMPLETED; FISTULA/ DEFECT FROM PROSTATIC URETHRA TO RECTUM UNABLE TO BE VISUALIZED. UTI ALSO NOTED POST IRE PROCEDURE. URETHRORECTAL FISTULA DIAGNOSED DUE TO URINE LEAKING FROM RECTUM DURING URINATION. CONSERVATIVE MANAGEMENT PROVIDED. PLAN IS TO KEEP FOLEY CATHETER INSITU FOR 4 WEEKS TO ALLOW FISTULA TO CLOSE. WILL REASSESS AT 4 WEEKS AND IF STILL PRESENT WILL REFER TO COLORECTAL RECONSTRUCTION SURGEON FOR MANAGEMENT AND SURGICAL CORRECTION. PHYSICIAN STATES UNSURE OF DIRECT CAUSE OF FISTULA. POSSIBLE CAUSE FROM UTI, REPEATED ELECTRODE PLACEMENT IN POSTERIOR ASPECT OF GLAND, FROM ABLATION OR ALL CONTRIBUTING FACTORS. WILL INFORM ANGIODYNAMICS UPON REASSESSMENT OF PATIENT IN 4 WEEKS.

  Patient problems: Fistula

  MAUDE report 20673379 ↗
• MalfunctionNov 13, 2024Arcing of Electrodes; Arcing of Electrodes

  DEVICE 1 OF 3: A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING THREE 15 CM IRE SINGLE ELECTRODE RFID ACTIVATION PROBES. PLACEMENT OF NANOKNIFE PROBES USING SURGICAL METAL CLAMPS TO FACILITATE MANIPULATION UNDER SCANNER CONTROL. DURING TREATMENT, ELECTRIC ARCS APPEAR ON THE PATIENT'S SKIN ON 3 DIFFERENT PROBES. EMERGENCY STOP OF THE PROCEDURE THEN REPLACEMENT OF THE PROBES WITH NEW ONES (WITHOUT MANIPULATION BY METAL CLAMPS). CORRECT TREATMENT, NO COMPLICATIONS OR HARM TO THE PATIENT. TREATMENT COMPLIANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673364 ↗
• MalfunctionNov 13, 2024Arcing of Electrodes; Arcing of Electrodes

  DEVICE 3 OF 3: A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING THREE 15 CM IRE SINGLE ELECTRODE RFID ACTIVATION PROBES. PLACEMENT OF NANOKNIFE PROBES USING SURGICAL METAL CLAMPS TO FACILITATE MANIPULATION UNDER SCANNER CONTROL. DURING TREATMENT, ELECTRIC ARCS APPEAR ON THE PATIENT'S SKIN ON 3 DIFFERENT PROBES. EMERGENCY STOP OF THE PROCEDURE THEN REPLACEMENT OF THE PROBES WITH NEW ONES (WITHOUT MANIPULATION BY METAL CLAMPS) CORRECT TREATMENT, NO COMPLICATIONS OR HARM TO THE PATIENT. TREATMENT COMPLIANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673356 ↗
• 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 ↗

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