Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 used for occlusion of th — recall Z-1209-2014

U.S. FDA — Device Enforcement · United States · 2014-01-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1209-2014
Date of alert: 2014-01-23
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Atricure Inc
Product category: device
Product type: Devices

Reported risk: The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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