NanoKnife 20400107Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI H787204001070), received between Aug 17, 2017 and Nov 13, 2024 — classified as 10 injuries.

2 other recalls cover devices cleared under the same FDA submission (K150089, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIODYNAMICS' SENIOR CLINICAL SPECIALIST REPORTED THAT POST PATIENT'S PROSTATE IRE PROCEDURE, THE PATIENT WAS IN RECOVERY AND HAD TO BE PLACED UNDER GENERAL ANESTHESIA DUE TO VITAL SIGNS. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED BRADYCARDIA APPROXIMATELY 15 TO 20 MINUTES POST PROCEDURE. THE PATIENT WAS TRANSPORTED IN STABLE CONDITION TO THE HOSPITAL FOR OBSERVATION. THERE WAS NO REPORTED DEVICE MALFUNCTION OR PROCEDURE ISSUES THAT CONTRIBUTED TO THE PATIENT'S ADVERSE EVENT. IT WAS REPORTED THAT PATIENT'S CO-MORBIDITY WAS A POSSIBLE CONTRIBUTING FACTOR TO THE EVENT. PER THE NURSE AT THE FACILITY, THE PATIENT WAS IMPROVING.

  Patient problems: Bradycardia

  MAUDE report 17550653 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER EXPERIENCED AN ISSUE WHEN USING A NANOKNIFE 15CM SINGLE ACTIVATION ELECTRODE PROBE. AFTER PLACING 4 NEEDLES UNDER CT GUIDANCE, THE DOCTOR INITIATED A TEST PULSE AND TISSUE CONDUCTIVITY TEST AT 10 PULSES/PROBE PAIR. ABOUT 30 SECONDS INTO THE FIRST 10 PULSES THE PATIENT HEART RATE DROPPED AND WENT ASYSTOLE FOR 12 SECONDS. THE PATIENT'S SINUS RHYTHM WAS NORMAL PRIOR TO IRE ENERGY AND PATIENT HAS NO KNOWN CARDIAC HISTORY. ANESTHESIA GAVE THE PATIENT A DRUG TO INCREASE THE HEART RATE ABOVE 90BPM. THE PROCEDURE PROCEEDED AGAIN WITH FIRST 10 PULSES AND THEN 100 PULSES PER PROBE PAIR WITH SUCCESS. GOOD CLINICAL OUTCOME FOR THE PATIENT WITH SUCCESSFUL RISE AND CURRENT AND CONFIRMATION WITH BOTH ULTRASOUND AND CT. PATIENT WAS NOT HARMED DURING COURSE OF TREATMENT.

  Patient problems: Low Cardiac Output

  MAUDE report 17201600 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT FILE IS BEING CANCELED AS IT IS BEING TRACKED AND REPORTED THROUGH THE DIRECT IDE TRIAL ASSOCIATED WITH PATIENT # (B)(6) OF THE DIRECT IDE TRIAL STUDY. THIS EVENT WILL BE ADJUDICATED BY THE CLINICAL ENDPOINTS COMMITTEE (CEC) AT A LATER DATE TO DETERMINE RELATIONSHIP WITH IDE.

  Patient problems: Bacterial Infection

  MAUDE report 11900018 ↗
• InjuryDec 29, 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 END USER REPORTED AN ISSUE DURING A PROCEDURE USING A 15 CM NANOKNIFE PROBE. DURING THE PROCEDURE, THE PATIENT WENT INTO TACHYCARDIA AND ATRIAL FLUTTER. THE PHYSICIAN AND ANESTHESIOLOGIST DECIDED TO PROCEED WITH THE TREATMENT. ULTIMATELY, IT WAS COMPLETED WITH THIS DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 11086956 ↗
• InjuryDec 27, 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 END USER REPORTED AN ISSUE DURING A PROCEDURE USING A 15 CM NANOKNIFE PROBE. DURING THE PROCEDURE, THE PATIENT WENT INTO TACHYCARDIA AND ATRIAL FLUTTER. THE PHYSICIAN AND ANESTHESIOLOGIST DECIDED TO PROCEED WITH THE TREATMENT. ULTIMATELY, IT WAS COMPLETED WITH THIS DEVICE AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Atrial Fibrillation; Tachycardia

  MAUDE report 11074084 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS REGIONAL BUSINESS MANAGER REPORTED RECEIVING FEEDBACK FROM A PHYSICIAN REGARDING THE 15CM NANOKNIFE PROBE. THE PHYSICIAN STATED THAT HE HAS SEEN SOME SIGNIFICANT SIDE EFFECTS WITH SOME OF HIS PATIENTS DUCTS AND VESSELS AFTER USING THE NANOKNIFE 15CM PROBES. THE TREATING PHYSICIAN STATED HE THOUGHT THEY HAD TRIED TO TREAT TOO LARGE OF A TUMOR. THE ABLATION HAD DESTROYED THE PANCREATIC DUCT CAUSING THE PATIENT TO HAVE A LARGE PANCREATIC LEAK. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION DURING THE PROCEDURE.

  Patient problems: Patient Problem/Medical Problem; Tissue Damage

  MAUDE report 10359621 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO ANGIODYNAMICS ON NOVEMBER 02, 2017: THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. "CT GUIDED IRE LIVER LESION WITH CLOSE APPROXIMATION TO THE RIGHT PORTAL VEIN. THE POST ABLATION CT REVEALS A COMPLETE COVERAGE OF THE LESION AND OPEN PORTAL VEIN. THREE (3) DAYS AFTER THE ABLATION, THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH PAIN IN THE RUQ. CT SCAN OF THE LIVER REVEALED LARGE NECROTIC AREA IN SEGMENT 5/8 OF THE LIVER. OCCLUSION OF THE PORTAL VEIN BRANCH TO SEGMENT 5/8 (NEXT TO THE ABLATION ZONE) WAS NOTED. DURING THE PROCEDURE, ANGIODYNAMICS' CLINICAL SPECIALIST (THAT WAS OBSERVING THE CASE), REPORTED HE HAD ASKED THE TREATING PHYSICIAN ABOUT THE DISTANCE OF THE NEEDLE TO THE PORTAL VEIN. THE PHYSICIAN REPORTED THE DISTANCE WAS EVEN INSIDE THE PORTAL VEIN. THE CLINICAL SPECIALIST MENTIONED TO THE PHYSICIAN THAT FOR SAFETY REASONS, IT WOULD BE ADVISABLE TO TRY TO REPOSITION IT AT LEAST 5 MM FROM THE PORTAL VEIN. THE PHYSICIAN REPOSITIONED THE NEEDLE AS MUCH AS POSSIBLE, DUE TO ANATOMY AND TUMOR POSITIONING. THE CLINICAL SPECIALIST CAN STATE WITH EXACTITUDE AT WHICH DISTANCE THE NEEDLE WAS REPOSITIONED, BUT MOST LIKEL

  Patient problems: Necrosis; Pain; Patient Problem/Medical Problem

  MAUDE report 7518020 ↗
• InjuryNov 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO ANGIODYNAMICS ON NOVEMBER 02, 2017: THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. AN IRE PROCEDURE FOR PANCREATIC CANCER HAD BEEN SUCCESSFULLY COMPLETED WITH NO REPORT OF PATIENT COMPLICATIONS OR DEVICE MALFUNCTIONS. POST PROCEDURE, DURING RECOVERY, THE PATIENT EXHIBITED A BLEED. DISTAL TO THE AREA OF THE ABLATION; BLEED OF DISTAL SMA (SUPERIOR MESENTERIC ARTERY). THE PATIENT WAS BROUGHT BACK TO THE OR WHERE BOTH THE TREATING PHYSICIAN AND A VASCULAR SURGEON ATTEMPTED TO STOP THE BLEED. THE TREATING PHYSICIAN STATED THAT HE DOESN'T BELIEVE THE COMPLICATION WAS RELATED TO THE NANOKNIFE PROCEDURE, AS THE BLEED OCCURRED DISTAL TO THE AREA OF THE ABLATION. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7067998 ↗
• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED TO ANGIODYNAMICS ON JULY 24, 2017: DURING AN IRE PROCEDURE OF THE LIVER, THE PATIENT EXPERIENCED V-TACH. THE PROCEDURE WAS ABORTED, AT WHICH TIME, THE PATIENT RESUMED NORMAL RHYTHM. THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT. IT WAS REPORTED THE DISPOSABLE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MEDICAL FACILITY DETERMINED NOT TO RETURN THE UNIT TO ANGIODYNAMICS FOR ASSESSMENT AS THE UNIT FUNCTIONED AS INTENDED.

  Patient problems: Ventricular Tachycardia

  MAUDE report 6800374 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150089, 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
• 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