NanoKnife H787204001110Recalls & reported problems
Angiodynamics, Inc. · NanoKnife Disposable Single Electrode 5 Probe Pack - Activation · Class 2
All models of NanoKnife (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K150089, K183385, K242687); 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.
Recalls naming this device
- Mar 2, 2023Class IIOpen, Classified
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
Z-1381-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K150089, K183385, K242687. 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 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
- Aliya Needle GTI-00023Galvanize Therapeutics, 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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