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

AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek¿ lid. A single-walled non-corrugated box completes the single unit package. Six (6) single unit PRO2 devi — recall Z-1148-2017

U.S. FDA — Device Enforcement · United States · 2016-11-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1148-2017
Date of alert: 2016-11-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: AtriCure, Inc.
Product category: device
Product type: Devices

Reported risk: A complaint of the PRO2 jaw breaking prior to surgery being performed.

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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