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.
What this means for you
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 th
- 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
Related recalls
Same manufacturer · Atricure Inc
See all →- HighTank hose assembly recalled for incorrect material and missing perforations
FDA (Devices) · 2024-02-07
- HighCryo Module Tank Hose Assemblies Recalled for Material and Design Defects
FDA (Devices) · 2024-02-07
- HighAtriCure EPi-Sense Guided Coagulation System Recalled for Compromised Sterile Seal
FDA (Devices) · 2019-07-03
- HighAtriCure Recalls COBRA FUSION 50 Ablation Systems Due to Thromboembolism Risk
FDA (Devices) · 2019-02-20
- SevereAtriCure COBRA FUSION 150 Ablation System Recalled for Thromboembolism Risk
FDA (Devices) · 2019-02-20
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02