Angiodynamics Accu2i pMTA Applicator Recall: Microwave Energy Failure Risk
Angiodynamics recalls Accu2i pMTA Applicators with potential microwave energy failure due to coolant ingress causing error codes. Affected units include specific model numbers and lots.
Lower-risk 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.
Contact the company
What happened, in plain English
Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators that may not function properly during use. This happens because coolant enters an electrical connection, causing the device to display a 'High Reflective Power' error code instead of delivering the intended microwave energy. Read more at govinfonow.com/recall/73947-angiodynamics-accu2i-pmta-applicator-recall-microwave-energy-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73947-angiodynamics-accu2i-pmta-applicator-recall-microwave-energy-failure-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0531-2018
Cite this page
“Angiodynamics Accu2i pMTA Applicator Recall: Microwave Energy Failure Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73947-angiodynamics-accu2i-pmta-applicator-recall-microwave-energy-failure-risk. Based on FDA recall #Z-0531-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0531-2018%22&limit=1).
Why it’s dangerous
Coolant can enter the electrical connection, causing the device to display a 'High Reflective Power' error code. This means the applicator won't deliver the intended microwave energy during tissue ablation procedures.
Who’s affected
Medical professionals using the Accu2i pMTA Applicator with Sulis V Generators are affected. The risk is low as the issue only affects the device's functionality, not causing injury.
How to tell if you have this one
Check for model number H787900602US0 and catalog number 900-602-US. The product was sold with Sulis V Generator REF 806-10 and includes specific production lots listed in the recall notice.
- Brand
Angiodynamics- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide
| Recall number | Product, codes & lots |
|---|---|
| Z-0526-2018 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, 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.; Lots: 15310411, 15320416, 15340428, 15350430, 15360434, 15380439, 15400449, 15420453, 15430454, 15440459, 15460466, 15470468, 15490476, 15500480, 15520487, 16010488, 16050494, 16070499, 16080502, 16100508, 16120512, 16140517, 16150520, 16170528, 16180530, 16190535, 16210540, 16230549, 16240550, 16250556, 16260561, 16270562, 16300568, 16310572, 16320573, 16350581, 16370590, 16380592, 16390595, 16400599, 16410603, 16420604, 16440611, 16450617, 17010645, 17020649, 17030653, 17040657, 17060662, 17070666, 17090673, 17100675, 17130686*, 17130687. |
| Z-0527-2018 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, 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.; Lots: 15310414, 15320417, 15340425, 15360433, 15370437, 15380441, 15390445, 15400451, 15470470, 15480472, 16050496, 16070501, 16130515, 16160525, 16190536, 16250558, 16320574, 16330579, 16420606, 16440612, 16460620, 16480630, 16500637, 17010646, 17030654, 17040659, 17070667, 17090672. |
| Z-0528-2018 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, 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.; Lots: 15310413, 15320415, 15340429, 15350431, 15360432, 15370435, 15380440, 15390444, 15400450, 15430456, 15440460, 15460467, 15470469, 15480471, 15490477, 15500481, 15520484, 16010489, 16050495, 16070500, 16080503, 16090506, 16100509, 16120513, 16150521, 16160523, 16170529, 16190534, 16230548, 16240551, 16250557, 16270563, 16300569, 16310571, 16320575, 16330577, 16350582, 16350586, 16370591, 16390596, 16410602, 16430610, 16440613, 16450618, 16460619, 16500636, 16510644, 17020651, 17040658, 17050660, 17060663, 17070668, 17100674, 17110678, 17130685. |
| Z-0529-2018 | 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.; 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. |
| Z-0530-2018 | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, 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.; Lots: 15330421, 15340426, 15370438, 15390447, 15400452, 15430458, 15440462, 15450465, 15480475, 15500482, 15520486, 16060497, 16100507, 16130516, 16140519, 16160526, 16180532, 16190537, 16240553, 16330580, 16350583, 16380594, 16410601, 16420607, 16430608, 16440616, 16460623, 16480629, 16500639, 17020652, 17090671, 17140694. |
| Z-0531-2018 | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, 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.; Lots: 15330420, 15370436, 15390448, 15430457, 15450464, 15480474, 15490479, 15520485, 16030491, 16140518, 16160527, 16180533, 16300570, 16320576, 16350584, 16440615, 16460622, 16480628, 16500640, 16510643, 17010648, 17030656. |
What to do — step by step
Check Device Status
Look for the error code 'High Reflective Power' on the microwave generator display to confirm if the device is malfunctioning.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0531-2018 (June 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0531-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.