GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Recall
- Recall Number
- Z-0291-2021
- Event Number
- 86421
- Firm
- W L Gore & Associates, Inc.
- FEI Number
- 2017233
- Product Code
- MIH
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 9, 2020
- Address
- 3750 W Kiltie Ln, Flagstaff, AZ, 86005-8712
Description
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
On 09/23/2020, the firm sent an "URGENT Medical Device Safety Correction" via First Class Postal (USPS) informing them that all lots of its Thoracic Stent Graft Systems may encounter difficulty withdrawing the delivery catheter due to a proximal stent apex being lodged with the delivery catheter leading olive. Customers are instructed to: Immediate Actions for the Recipient: - Take note of amendment/reinforcement of Instructions For Use (IFU) - Please respond to the enclosed acknowledgement - Please share this letter with others in your hospital or clinic as appropriate The Recalling Firm is providing physicians with this information so that appropriate risk-related decisions can be made with the patient when considering the Conformable Thoracic Stent Graft System. The Recalling Firm maintains its confidence in the safety and efficacy of the device and will not be removing the affected products from the market. There are no actions required for patients already implanted with the Thoracic Stent Graft. Please contact the Recalling Firm's Customer Service (email: [email protected] or by phone at 800-528-8763) with any questions related to this letter.
U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom
19013 units