Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators
Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 (inability to deliver energy) without reporting any injuries, illnesses, or hospitalizations, aligning with the criteria for a moderate severity score.
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-US. The affected lots were distributed worldwide and nationwide in the United States.
The recall was initiated because the product has the potential to not function during use. Specifically, coolant ingress in an electrical connection may prevent the applicator from delivering the desired microwave energy. When this condition occurs, the microwave generator displays an error code for High Reflective Power.
Healthcare providers and facilities should stop using the affected applicators and contact Angiodynamics, Inc. for further instructions regarding the recall.
The recalled product
- Product
- 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…
- 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: 15310412
- 15330419
- 15340427
- 15390446
- 15430455
- 15440461
- 15450463
- 15480473
- 15490478
- 16030490
- 16060498
- 16130514
- 16160524
- 16180531
- 16240552
- 16260560
- 16330578
- 16350585
- 16380593
- 16400600
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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