NanoKnife 20400109Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787204001090), received between Sep 9, 2020 and Sep 17, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Arcing” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A GLOBAL SCIENTIFIC AND CLINICAL AFFAIRS MANAGER REPORTED AN PATIENT EXPERIENCED AN ISSUE POST PROCEDURE ASSOCIATED WITH THE USE OF A NANOKNIFE PROBE. ON (B)(6) 2024 PATIENT RECEIVED AN IRE TREATMENT TO RIGHT ANTERIOR TRANSITION ZONE OF PROSTATE. PATIENT DEVELOPED PELVIC PAIN AND URINARY RETENTION WEEK AFTER AND WENT TO ER. CT SCAN COMPLETED AND SUSPECT URETHRORECTAL FISTULA NOTED. URINARY CATHETER LEFT IN PLACE AND PATIENT ON ANTIBIOTICS. PATIENT BEING SCHEDULED FOR MPMRI IN NEXT COUPLE WEEKS FOR DEFINITIVE DIAGNOSIS. ADDITIONAL INFORMATION: RECEIVED A CLINICAL UPDATE FROM DR. ROTHBERG ON THURSDAY MAY 23RD. PATIENT RECEIVED FOLEY CATHETER INSERTIONS POST PROCEDURE IN ER AS WELL AS UROLOGY CLINIC. SPECIFIC DATES NOT PROVIDED. CYSTOSCOPY COMPLETED ON THURSDAY MAY 23RD FOR ASSESSMENT. FISTULA NOTED DISTAL TO IRE ABLATION AREA. PRESUMED FISTULA FROM TRAUMATIC FOLEY CATHETER INSERTION POST IRE TREATMENT.

  Patient problems: Fistula

  MAUDE report 19457749 ↗
• InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE THAT OCCURRED DUE TO A NANOKNIFE TREATMENT. POST PROCEDURE, THE PATIENT STARTED HAVING NAUSEA/VOMITING & INCREASING WBC COUNT SO A CT SCAN WAS PERFORMED. THE SCAN INDICATED THE PATIENT WAS EXPERIENCING A PANCREATIC DUCT LEAK AFTER TREATMENT. A SECOND DRAIN WAS PLACED TO DRAIN THE POOL OF PANCREATIC FLUID. IT WAS REPORTED THAT IS PATIENT IS OKAY. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: Fluid Discharge

  MAUDE report 10507152 ↗

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