NanoKnife 20400103Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI H787204001030), received between Feb 17, 2021 and Apr 22, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (4 reports).

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

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT EXPERIENCED A COMPLICATION APPROXIMATELY 9 DAYS AFTER A NANOKNIFE PROCEDURE USING A 15 CM IRE SINGLE ELECTRODE RFID ACTIVATION PROBE. THE PATIENT WAS REPORTED AS HAVING "INFECTED SYNDROME AND AERO NECROSIS" AT THE ABLATION SITE IN THE LIVER. THIS WAS NOTICED DUE TO THE PATIENT EXPERIENCING SEVER INFECTION SYNDROME. THE PATIENT WAS HOSPITALIZED AND REPORTEDLY WAS TREATED WITH ANTIBIOTICS. THERE WERE NO REPORTED PATIENT COMPLICATIONS OR DEVICE MALFUNCTION DURING THE PROCEDURE.

  Patient problems: Bacterial Infection; Necrosis

  MAUDE report 17155528 ↗
• MalfunctionAug 23, 2022Arcing of Electrodes; Arcing of Electrodes

  A DISTRIBUTOR REPORTED AN ISSUE WITH A 15 CM IRE SINGLE ELECTRODE RFID ACTIVATION PROBE. THE FOLLOWING WAS REPORTED: "THERE WAS A HIGH CURRENT SPIKE THAT OCCURRED BETWEEN ELECTRODE PAIR 1-4. WE ALSO OBSERVED A SPARK AT THE BRACHYTHERAPY PLACEMENT GRID WHICH HAS NOT HAPPENED BEFORE. WE WERE UNSURE OF THE CAUSE AS THE OTHER PROBE PAIRS WERE SUCCESSFULLY DELIVERED. WE CHANGED THE ELECTRICAL POLARITY OF PROBE 4 TO BE POSITIVE FOR ALL PAIRS. THE PROCEDURE WAS CONTINUED TO ADMINISTER THE REMAINING 10 PULSES BETWEEN ELECTRODE PAIRS 1-4. A SPARK WAS AGAIN SEEN OUTSIDE THE PATIENT AT THE BRACHYTHERAPY GRID ON THE ELECTRODE. IT WAS DECIDED TO REMOVE ELECTRODE 4 AND REPLACE IT WITH ANOTHER ELECTRODE OF THE SAME IN THE SAME POSITION. THE PROCEDURE WAS THEN COMPLETED AS NORMAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278676 ↗
• MalfunctionOct 19, 2021Material Discolored; Melted; Material Discolored; Melted

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WITH A NANOKNIFE ELECTRODE. AFTER OPENING THE PROBE PACKAGING, BUT BEFORE STARTING THE PROCEDURE, PHYSICIAN NOTICED THAT THE TIP OF PROBE IS DARK, IT LOOKED AS IF ITS BURNT/CHARRED. THE PROBE HAD NOT BEEN PLACED. IT WAS REPORTED THE PROBE WAS CONNECTED TO THE UNIT AT THE TIME. THE PROCEDURE HAD NOT BEEN STARTED AND THE PROBE HAD NOT BEEN ACTIVATED, HOWEVER THE UNIT WAS ON AT THE TIME. THE UNIT WAS SET TO BURN AT 2700V. IT WAS SET ASIDE AND THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658577 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  1ST PROBE: A PRODUCT SPECIALIST REPORTED AN ISSUE, POST PROCEDURE, WITH THE PATIENT. THE FOLLOWING WAS REPORTED: "IRE CASE REPORT WE RECEIVED INFORMATION FROM (B)(6) HOSPITAL, THEY HAVE SOME PROBLEMS IN ONE PATIENT ABOUT VESSEL THROMBOSIS AFTER TREATMENT WITH IRE ON (B)(6) 2020, WITH THE DETAILS BELOW. PATIENT HAVE AN APPOINTMENT TREATMENT WITH IRE ON (B)(6) 2020 AT 9:00AM. WE NORMALLY PLACE NEEDLE AROUND LESION, THE LESION SIZE IS 3. 3CM. X 3.1CM. X 2.8CM. USED 5 NEEDLES IN THIS CASE. NEEDLE DISTANCE IN PLAIN BODY 1.000 FOLDER OF THE RAR FILE. NEEDLE POSITION IN PLAIN BODY 2.0 FOLDER OF THE RAR FILE. CT SCAN AFTER DONE IN BODY 2.0 CE FOLDER, NO PROBLEMS FOUND. AFTER IRE TREATMENT 1 WEEK FOLLOW UP ON (B)(6) 2020. AFTER IRE TREATMENT 1 MONTH FOLLOW UP ON (B)(6) 2020. AFTER IRE TREATMENT 2 MONTHS FOLLOW UP ON (B)(6) 2020, VESSEL THROMBOSIS WAS FOUND UNDER ULTRASOUND. DOCTOR (B)(6). AFTER IRE TREATMENT 3 MONTHS FOLLOW UP ON (B)(6) 2020. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11337280 ↗

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