NanoKnife 20400111Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI H787204001110), received between Apr 18, 2024 and Oct 27, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER REPORTED AN ADVERSE PATIENT IMPACT POST NANOKNIFE PROCEDURE THAT USED A 5-PROBE PROCEDURE PACK-ACTIVATION, 15CM. IT WAS REPORTED THE PATIENT EXPERIENCED A RECTOPROSTATIC FISTULA AND NECROTIC PROSTATE. NO FURTHER EVENT INFORMATION WAS PROVIDED, AND NO REPORT OF PRODUCT MALFUNCTION PROVIDED. THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT POST PROCEDURE. THERE WAS NO REPORT OF A DEVICE MALFUNCTION DURING THE PROCEDURE.

  Patient problems: Fistula; Necrosis

  MAUDE report 19133816 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN END USER REPORTED AN ADVERSE PATIENT IMPACT POST NANOKNIFE PROCEDURE THAT USED A 5-PROBE PROCEDURE PACK-ACTIVATION, 15CM. IT WAS REPORTED THE PATIENT EXPERIENCED TOTAL NECROSIS OF THE PROSTATIC URETHRA WITH UTIS AND RETENTION, AND NEEDED TURP. NO FURTHER EVENT INFORMATION WAS PROVIDED, AND NO REPORT OF PRODUCT MALFUNCTION PROVIDED. THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT POST PROCEDURE. THERE WAS NO REPORT OF A DEVICE MALFUNCTION DURING THE PROCEDURE.

  Patient problems: Necrosis; Urinary Tract Infection

  MAUDE report 19133815 ↗

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