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U.S. Department of Health and Human Services

Class 2 Device Recall Gore Cardioform Septal Occluder

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  Class 2 Device Recall Gore Cardioform Septal Occluder see related information
Date Initiated by Firm December 14, 2022
Date Posted February 01, 2023
Recall Status1 Open3, Classified
Recall Number Z-1048-2023
Recall Event ID 91380
Product Classification Transcatheter septal occluder - Product Code MLV
Product GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Code Information UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
Recalling Firm/
Manufacturer		 W L Gore & Associates, Inc.
3750 W Kiltie Ln
Flagstaff AZ 86005-8712
For Additional Information Contact
928-864-3600
Manufacturer Reason
for Recall		 Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.
FDA Determined
Cause 2		 Employee error
Action On 12/14/22, recall notices were mailed to customers informing them to take the following actions: 1) Identify and return any unused devices. 2) Complete and return the customer response form to to FieldActionTeam@wlgore.com 3) This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred. Customers with questions can contact the firm at MPDCustomerCare@wlgore.com
Quantity in Commerce 14
Distribution US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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