Angiodynamics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0529-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Product Classification:

Class II

Date Initiated: June 5, 2017

Date Posted: February 14, 2018

Recall Number: Z-0529-2018

Event ID: 77631

Reason for Recall:

The firm is recalling product that has the potential to not function during use. The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.

Status: Terminated

Product Quantity: 14,353 units in total

Code Information:

Lots: 15310412, 15330419, 15340427, 15390446, 15430455, 15440461, 15450463, 15480473, 15490478, 16030490, 16060498, 16130514, 16160524, 16180531, 16240552, 16260560, 16330578, 16350585, 16380593, 16400600, 16420605, 16430609, 16440614, 16460621, 16500638, 16510642, 17010647, 17020650, 17030655, 17050661, 17060664, 17080669, 17110676.

Distribution Pattern:

Worldwide distribution - US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated