AtriCure Recalls Reusable Clip Appliers Due to Cracked Spring
AtriCure is recalling 46 Reusable Clip Appliers because a customer reported a cracked spring in the handle. The devices were distributed nationwide.
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 2/5 (Moderate).
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. The source text describes a mechanical defect (cracked spring) but does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall.
Plain-English summary
AtriCure, Inc. is recalling 46 units of the Reusable Clip Applier, manufactured in West Chester, Ohio. The device is intended to be used to deploy the Gillinov-Cosgrove LAA Clip, an implantable device used for occlusion of the left atrial appendage.
The recall was initiated after the firm was notified by a customer of a cracked spring in the handle of the RCD1 device. The affected units are identified by Lot Number MFR-0424-1.
The recalled devices were distributed nationwide, including in the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA, and WA. Users should stop using the device and contact AtriCure for instructions on return or replacement.
The recalled product
- Product
- Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device…
- Manufacturer
- Atricure Inc
- Hazard
- Affected units
- 46
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)
- Lot Number MFR-0424-1
Distribution
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