Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators
Angiodynamics, Inc. 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (failure to deliver energy) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Angiodynamics, Inc. is recalling 14,353 units of the Accu2i pMTA Microwave Tissue Ablation Applicator, 19 cm INTERMEDIATE (REF/Catalog # 900-602-US). The affected lots were distributed worldwide and across the United States.
The recall is due to a potential failure where coolant ingress in an electrical connection prevents the product from delivering the desired microwave energy. This condition results in an error code for High Reflective Power being displayed on the microwave generator. The product is indicated for the intraoperative coagulation of soft tissue and is only for use with a Sulis V Generator.
Healthcare providers and facilities should stop using the affected applicators and contact Angiodynamics, Inc. for instructions on return or replacement.
The recalled product
- Product
- 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…
- 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: 15330420
- 15370436
- 15390448
- 15430457
- 15450464
- 15480474
- 15490479
- 15520485
- 16030491
- 16140518
- 16160527
- 16180533
- 16300570
- 16320576
- 16350584
- 16440615
- 16460622
- 16480628
- 16500640
- 16510643
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.
See all 6 products in this recall →Related recalls
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