Z-0073-2022Class II

AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm...

Name: Z-0073-2022 AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm...
Creator: Angiodynamics, Inc.
Published: 2020-04-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-04-24 / Terminated / root cause: software

FDA source

Angiodynamics, Inc. began a recall of AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog... on 2020-04-24. FDA classified it as Class II and gives the reason as "Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0073-2022
Classification: Class II
Status: Terminated
Initiated: 2020-04-24
Posted: 2021-10-07
Terminated: 2022-09-20
Recalling firm: Boston Scientific Corporation
Product: AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
Product code: OAB Low Energy Direct Current Thermal Ablation System
Reason for recall: Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: On April 24, 2020, the firm distributed recall notifications to their consignees, who were all international (non-US). Customers were advised to stop using the recalled product, remove it from inventory, and segregate in a secure location for return. The firm provided further instructions for the return of the product.
Quantity in commerce: 37
Distribution: Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.
Product codes and lots: lot 5577754

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0073-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0073-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-13	2021-10-07

Product code OAB

K150089Class IINanoKnife SystemAngioDynamics, Inc. / cleared 2015-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)