Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AtriCure Reusable Clip Applier

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall AtriCure Reusable Clip Appliersee related information
Date Initiated by FirmJanuary 23, 2014
Date PostedMarch 14, 2014
Recall Status1 Terminated 3 on May 13, 2014
Recall NumberZ-1209-2014
Recall Event ID 67572
Product Classification Applier, hemostatic clip - Product Code HBT
ProductReusable 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 the left atrial appendage.
Code Information Lot Number MFR-0424-1
FEI Number 3011706110
Recalling Firm/
Manufacturer		 Atricure Inc
6217 Centre Park Drive
West Chester OH 45069
For Additional Information ContactMr. Anupam K. Bedi
513-755-4563
Manufacturer Reason
for Recall		The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 1/24/2014 the firm sent Urgent Recall Notification letters to their customers.
Quantity in Commerce46 units
DistributionNationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
-
-