Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators
Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering desired microwave energy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional failure (lack of energy delivery) with no reported injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Angiodynamics, Inc. is recalling 14,353 units of the Accu2i pMTA Microwave Tissue Ablation Applicator, 14 cm STANDARD (REF/Catalog # 900-600, Model # H7879006000). The affected sterile applicators are indicated for the intraoperative coagulation of soft tissue and are intended for use only with a Sulis V Generator (REF 806-10). The recall covers specific lots distributed worldwide and across the United States.
The recall is being conducted because the product has the potential to not function during use. Coolant ingress in an electrical connection may prevent the applicator from delivering the desired microwave energy. This condition results in an error code labeled "High Reflective Power" being displayed on the microwave generator.
Healthcare providers and facilities that have purchased or received these specific lots should stop using the affected applicators and contact Angiodynamics, Inc. for further instructions on how to return or dispose of the product. Patients who have undergone procedures using these devices should consult their healthcare provider if they have concerns about the procedure's outcome.
The recalled product
- Product
- 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 co
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 14,353
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots: 15310411
- 15320416
- 15340428
- 15350430
- 15360434
- 15380439
- 15400449
- 15420453
- 15430454
- 15440459
- 15460466
- 15470468
- 15490476
- 15500480
- 15520487
- 16010488
- 16050494
- 16070499
- 16080502
- 16100508
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Angiodynamics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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