Recall Z-1148-2017— AtriCure, Inc.
Class II · Terminated
Class II FDA medical device recall by AtriCure, Inc., initiated 2016-11-30, terminated 2018-02-15. It names one FDA 510(k) clearance: K160454. Product: 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 devices are packaged into one (1) corrugate shipper box.. Reason: A complaint of the PRO2 jaw breaking prior to surgery being performed..
- Recalling firm
- AtriCure, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-30
- Terminated
- 2018-02-15
- Firm location
- Mason, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 devices are packaged into one (1) corrugate shipper box.
Reason for recall
A complaint of the PRO2 jaw breaking prior to surgery being performed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.