Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators
Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators that may fail to deliver energy due to coolant ingress.
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 is classified as FDA Class II. The hazard is a risk-of-harm product failure (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). The affected products are sterile and intended for use with a Sulis V Generator (REF 806-10) for the intraoperative coagulation of soft tissue.
The recall is due to a potential failure where the product does not deliver the desired microwave energy. This condition is caused by coolant ingress in an electrical connection, which results in a 'High Reflective Power' error code being displayed on the microwave generator. The affected lots were distributed worldwide and nationwide in the US.
Healthcare providers and facilities should stop using the affected applicators and contact Angiodynamics, Inc. for instructions on how to return or dispose of the products. Patients who have already undergone procedures using these devices should contact their healthcare provider if they have concerns about the procedure's outcome.
The recalled product
- Product
- 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…
- Manufacturer
- Angiodynamics, Inc.
- 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: 15310413
- 15320415
- 15340429
- 15350431
- 15360432
- 15370435
- 15380440
- 15390444
- 15400450
- 15430456
- 15440460
- 15460467
- 15470469
- 15480471
- 15490477
- 15500481
- 15520484
- 16010489
- 16050495
- 16070500
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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