NanoKnife 20400101Recalls & reported problems
Angiodynamics, Inc. · NanoKnife Disposable Single Electrode Probe · Class 2
All models of NanoKnife (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI H787204001015), received between Oct 11, 2016 and Oct 11, 2016 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED (B)(6) 2016, ON (B)(6) 2016, A PATIENT OF UNKNOWN AGE AND GENDER HAD PRESENTED FOR AN IRE (IRREVERSIBLE ELECTROPORATION) PROCEDURE OF THE PANCREAS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORT OF COMPLICATIONS OR DEVICE MALFUNCTIONS, INCLUDING A GOOD IMMEDIATE POST CT SCAN. IT WAS REPORTED THAT APPROXIMATELY 4 WEEKS POST PROCEDURE, VIA A CT SCAN, THE TREATING PHYSICIAN NOTED A "NECROTIC AREA AND SOME GAS BUBBLES" AT THE ABLATION SITE. AT APPROXIMATELY 6-7 WEEKS POST PROCEDURE, IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A GI BLEED FROM THE GBD (GASTRODUODENAL ARTERY) WHICH RUNS THROUGH THE ABLATION SITE. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION AS TO THE PATIENT'S WELL BEING IN REGARDS TO THE EVENT. IT WAS REPORTED THE DISPOSABLE NANOKNIFE PROBE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Patient problems: Blood Loss
MAUDE report 6016434 ↗
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 · TerminatedAngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
Other Low energy direct current thermal ablation system devices
- NanoKnife H787204001110Angiodynamics, Inc. · Low energy direct current thermal ablation system1 recall0 reports
- NanoKnife 20400107Angiodynamics, Inc. · Low energy direct current thermal ablation system10 reports
- NanoKnife 20400103Angiodynamics, Inc. · Low energy direct current thermal ablation system8 reports
- NanoKnife 20300301USAngiodynamics, Inc. · Low energy direct current thermal ablation system1 death8 reports
- NanoKnife 20400104Angiodynamics, Inc. · Low energy direct current thermal ablation system6 reports
- NanoKnife 20400111Angiodynamics, Inc. · Low energy direct current thermal ablation system4 reports
- NanoKnife 20300101Angiodynamics, Inc. · Low energy direct current thermal ablation system4 reports
- NanoKnife 20400109Angiodynamics, Inc. · Low energy direct current thermal ablation system3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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