Atricure Max1 Isolator Transpolar Pen Recalled for Incorrect Labeling
Atricure Inc. is recalling five Max1 Isolator Transpolar Pens due to incorrect Instructions for Use labeling.
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, and the hazard is limited to incorrect labeling (documentation issue) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Atricure Inc. is recalling five units of the Max1 Isolator Transpolar Pen, Model A000163, Lot Number 41865. These medical devices are used to ablate cardiac tissues during surgery or for temporary cardiac pacing and sensing.
The recall was initiated because products from this specific lot may have been distributed with incorrect Instructions for Use (IFU) labeling. The devices were distributed nationwide, including in Maryland, Pennsylvania, and Texas.
Healthcare providers and facilities that have received these devices should stop using them and contact Atricure Inc. for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during…
- Manufacturer
- Atricure Inc
- Hazard
- Affected units
- 5
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 (2)
- Model Number(s): MAX1 A000163
- Lot Number 41865
Distribution
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