Reported Nov 30, 2016 · Terminated
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model…
AtriCure, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AtriCure, Inc. · 7555 Innovation Way · Mason, OH · 45040-9695
Is this the product you have?
COBRA Fusion 50 Ablation SystemCOBRA Fusion 150 Ablation Systemand COBRA Fusion Magnetic Retriever System
- Model Numbers700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU)
- Lot codes and dates
- Specifically all lots manufactured prior to February 2016. This information can be identified as the symbol for "date of manufacture"
- on the product label asMM-YYYY, e.g. 02-2016 or earlier
- Amount recalled
- 5,263
Where it was sold
Why it was recalled
Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.
This product could cause temporary or reversible health problems — stop using it.
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