NanoKnife 20400104Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI H787204001040), received between Jan 29, 2019 and Oct 17, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Arcing of Electrodes; Arcing of Electrodes

  1ST DEVICE:AN END USER REPORTED AN ISSUE WITH TWO 15 CM IRE SINGLE ELECTRODE NEEDLES. DURING A PROCEDURE, WHEN THE NEEDLES WERE OUTSIDE OF THE PATIENT, A SPARK BETWEEN THE TWO NEEDLES WAS OBSERVED. THERE WAS NO EVIDENCE OF SMOKE AND NO BURNING SMELL AND THE PROCEDURE WAS PERFORMED FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED WITH THESE NEEDLES AND THE PATIENT, NOR PHYSICIAN, EXPERIENCED ANY ADVERSE EFFECTS, HARM, OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. REPORTEDLY, THE PHYSICIAN IS EXPERIENCED AND IS ALWAYS SUPPORTED BY A CLINICAL SPECIALIST FROM MCM MEDSYS AG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948964 ↗
• MalfunctionOct 17, 2023Arcing of Electrodes; Arcing of Electrodes

  2ND DEVICE: AN END USER REPORTED AN ISSUE WITH TWO 15 CM IRE SINGLE ELECTRODE NEEDLES. DURING A PROCEDURE, WHEN THE NEEDLES WERE OUTSIDE OF THE PATIENT, A SPARK BETWEEN THE TWO NEEDLES WAS OBSERVED. THERE WAS NO EVIDENCE OF SMOKE AND NO BURNING SMELL AND THE PROCEDURE WAS PERFORMED FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED WITH THESE NEEDLES AND THE PATIENT, NOR PHYSICIAN, EXPERIENCED ANY ADVERSE EFFECTS, HARM, OR REQUIRED MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. REPORTEDLY, THE PHYSICIAN IS EXPERIENCED AND IS ALWAYS SUPPORTED BY A CLINICAL SPECIALIST FROM MCM MEDSYS AG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948955 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  3RD 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 11336929 ↗
• InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem

  2ND 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 11336928 ↗
• InjuryJul 12, 2019Adverse 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. DURING IRE ENERGY DELIVERY TO LIVER, PATIENT DEVELOPED SVT. ENERGY DELIVERY WAS PAUSED AND CHEMICAL CARDIOVERSION WAS ATTEMPTED. IRE ENERGY DELIVERY WAS RESUMED. AT THE END OF IRE ENERGY DELIVERY, THE SVT PERSISTED. ELECTRICAL CARDIOVERSION WAS AGAIN ATTEMPTED. THE PATIENT WAS ADMITTED FOR 2 DAYS POST PROCEDURE FOR CARDIOLOGY MONITORING AND FOLLOW-UP. THE PATIENT HAS BEEN REPORTED AS STABLE. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER AS IT WAS DISPOSED OF BY THE USER.

  Patient problems: Arrhythmia

  MAUDE report 8784791 ↗
• MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT OF UNKNOWN AGE AND GENDER PRESENTED FOR AN IRE PROCEDURE VIA PERINEUM ACCESS. IT WAS REPORTED THAT WHEN ATTEMPTING TO INSERT THE PROBE, A PIECE OF THE INSULATION SLEEVE BROKE OFF. AS THE INSULATION SLEEVE FRACTURED OUTSIDE OF THE PATIENT, THERE WAS NO PATIENT HARM OR INJURY. IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE INCIDENT IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286808 ↗

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