Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators
Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering 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 functional defect that prevents it from performing its intended therapeutic action during surgery. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Angiodynamics, Inc. is recalling 14,353 units of the Accu2i pMTA Microwave Tissue Ablation Applicator, 29 cm LONG, REF/Catalog # 900-601-US. The affected products are sterile and indicated for the intraoperative coagulation of soft tissue. The recall covers units distributed worldwide and across the United States.
The recall is being conducted 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 that have received these products should stop using them and contact the recalling firm for further instructions. The recall includes specific lot numbers ranging from 15330421 to 17140694.
The recalled product
- Product
- 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…
- 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: 15330421
- 15340426
- 15370438
- 15390447
- 15400452
- 15430458
- 15440462
- 15450465
- 15480475
- 15500482
- 15520486
- 16060497
- 16100507
- 16130516
- 16140519
- 16160526
- 16180532
- 16190537
- 16240553
- 16330580
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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