AtriClip LAA Exclusion System Recalled for Potential Component Failure
AtriCure, Inc. is recalling 298 AtriClip LAA Exclusion Systems due to a potential component failure that could require medical intervention.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
AtriCure, Inc. is recalling 298 units of the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip. This medical device is used for the occlusion of the heart's left atrial appendage under direct visualization during open cardiac surgical procedures. The recall is being conducted because there is a potential for a component failure of the device, which could necessitate medical intervention.
The affected products include Model Numbers PRO235, PRO240, PRO245, and PRO250, with Lot Numbers ranging from 65622 to 66773. The devices were distributed nationwide to the following states: AL, AR, AZ, CA, CT, FL, GA, IL, KS, MD, MI, MN, MO, MS, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, and WI. The product was also shipped to Poland and Switzerland.
Healthcare providers and patients who have used or may have used these specific devices should contact AtriCure, Inc. for further instructions regarding the recall and potential medical intervention.
The recalled product
- Product
- AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
- Manufacturer
- AtriCure, Inc.
- Hazard
- Affected units
- 298
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 (3)
- Model Numbers: PRO235
- PRO240
- PRO245 and PRO250 Lot Numbers: 65622 to 66773
Distribution
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