The Recall Desk
SevereFDA (Devices)·Z-0653-2017·Announced 2016-11-30

AtriCure Recalls COBRA Fusion Ablation Systems Due to Component Separation Risk

AtriCure is recalling COBRA Fusion Ablation Systems because a part may separate and remain in the body, potentially causing permanent impairment or damage.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of permanent impairment or damage to body function or structure, which aligns with the 'Severe' criteria for significant injury reports or high-risk structural defects.

Plain-English summary

AtriCure, Inc. is recalling the COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. The affected model numbers are 700-001, 700-001S, 700-001MI, 700-002, and 700-003. These devices are intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy when connected to an Estech Electrosurgical unit.

The recall is due to product design and process control issues that can cause part of the device to separate and remain behind when the device is removed. This retained material can potentially cause permanent impairment or damage to body function or structure. The recall covers 5,263 units manufactured prior to February 2016, identified by a date of manufacture symbol on the product label showing MM-YYYY, such as 02-2016 or earlier.

The affected devices were distributed worldwide, including in the United States and various international countries. Healthcare providers and facilities should stop using the affected devices and contact AtriCure for further instructions on the recall.

The recalled product

Product
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when con
Manufacturer
AtriCure, Inc.
Category
Medical Device — Cardiac Ablation
Hazard
Affected units
5,263

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 (1)

  • e.g. 02-2016 or earlier.

Distribution

Distributed in 37 states:

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