CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report
Accu2i pMTA Applicator LONG recalled by Angiodynamics
Angiodynamics is recalling Accu2i pMTA Applicator LONG, distributed nationwide in the US. The recall was initiated on 5 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0530-2018
- FDA event ID
- 77631
- Recalling firm
- Angiodynamics, Queensbury, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2017
- FDA classified
- 5 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Jun 2017 | Recall initiated by company | |
| 5 Feb 2018 | Classified by FDA | +245 days |
| 14 Feb 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide
Questions about this recall
Is Accu2i pMTA Applicator LONG recalled?
Yes. Angiodynamics recalled Accu2i pMTA Applicator LONG on 5 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0530-2018.
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution - US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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