Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators Due to Malfunction
Angiodynamics, Inc. is recalling 14,353 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 risk of harm (failure to deliver energy during surgery) 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, 29 cm LONG (REF/Catalog # 900-601, Model # H7879006010). The recalled 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 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 identify any affected units by checking the lot numbers listed in the recall notice. If a device is found to be affected, it should be removed from service and returned to Angiodynamics, Inc. according to the firm's instructions.
The recalled product
- Product
- Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, 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: 15310414
- 15320417
- 15340425
- 15360433
- 15370437
- 15380441
- 15390445
- 15400451
- 15470470
- 15480472
- 16050496
- 16070501
- 16130515
- 16160525
- 16190536
- 16250558
- 16320574
- 16330579
- 16420606
- 16440612
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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