PlainRecalls

Atricure Inc

11 recalls on record · Latest: Feb 7, 2024

Atricure Inc Recall Insight

Atricure Inc appears on 11 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.013% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 7, 2024, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 11 entries, severity tagging shows 0 critical, 11 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 11 of 11 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (11). The date window on this page runs from Mar 13, 2013 to Feb 7, 2024.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 7, 2024

Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

FDA Devices Moderate Feb 7, 2024

Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

FDA Devices Moderate Feb 20, 2019

COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI

FDA Devices Moderate Feb 20, 2019

COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S

FDA Devices Moderate Feb 20, 2019

COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001

FDA Devices Moderate Feb 20, 2019

COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002

FDA Devices Moderate Feb 15, 2017

AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene …

FDA Devices Moderate Nov 30, 2016

COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700…

FDA Devices Moderate Jan 7, 2015

Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery.…

FDA Devices Moderate Mar 26, 2014

Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is inten…

FDA Devices Moderate Mar 13, 2013

Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds