—#103817

Product

ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).

FDA product code: OAB — Low Energy Direct Current Thermal Ablation System
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K080376
Affected lot / code info: Batch/Serial Numbers: 00120508, 00090508, 00880909, 00371008, 00670709, 00850909, 00890909, 00780709, 00220708, 00300708, 00951009, 00900909, 00800709, 00260708, 00650709, 00690709, 00920909, 00930909, 00770709, 00130508, 01001009.

Why it was recalled

Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture.

Root cause (FDA determination)

Component design/selection

Action the firm took

AngioDynamics, Inc. sent a "NOTIFICATION OF MEDICAL DEVICE CORRECTION" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice.

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Avenue, Queensbury, New York 12804

Distribution

Distribution pattern: Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain,

Timeline

Recall initiated: 2011-04-04
Posted by FDA: 2011-09-23
Terminated: 2016-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.