Z-0918-2012

NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch...

Name: Z-0918-2012 NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch...
Creator: Angiodynamics Worldwide Headquarters
Published: 2012-01-20
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2012-01-20 / Terminated / root cause: labeling and UDI

FDA source

Angiodynamics Worldwide Headquarters began a recall of NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by... on 2012-01-20. The reason FDA records is "Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0918-2012
Status: Terminated
Initiated: 2012-01-20
Posted: 2012-01-27
Terminated: 2016-02-10
Recalling firm: Angiodynamics Worldwide Headquarters
Product: NanoKnife Irreversible Electroporation System. System consists of multiple components: Generator, footswitch, disposable electrode. System is manufactured by AngioDynamics, Inc. --- Catalog #20300101 Intended use: the generator system with six outputs is indicated for surgical ablation of soft tissue.
Product code: OAB Low Energy Direct Current Thermal Ablation System
Reason for recall: Angiodynamics was marketing the NanoKnife System with the ablation zone estimator feature in the US without FDA clearance.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: AngioDynamics sent an Urgent - Medical Device Correction letter dated December 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use the User's Manual that was supplied with the generator when it was purchased. Instructions include discarding their current manual and troubleshooting guide. A replacement manual will be provided with the Field Safety Notice; the troubleshooting guide will not be replaced. Customers were instructed to complete the Reply Form and fax to AngioDynamics at 518-798-1360. If customers further distributed the affected product, they should inform those accounts of the field correction. Angiodynamics will also disable the AZE feature during a schedule service visit. For questions regarding this recall call 1-800-772-6446 or e-mail [email protected].
Quantity in commerce: 40 units
Distribution: Nationwide Distribution
Product codes and lots: Batch codes: 00800709, 00880909, 00870909, 00630609, 00610609, 00470109, 00080508, 00180608, 00050508, 00460109, 00830709, 00240708, 00500209, 00930909, 00430109, 00480209, 00371008, 01210911, 00650709, 00670709, 00690709, 00850909, 00920909, 00820709, 00860909, 00890909, 00940909, 00780709, 00770709, 00760709, 00910909, 00790709, 00361008, 00750709, 00510209, 00450109, 00421208, 00490209, 00530209, 00600609

Product code OAB

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)