Recall Z-0291-2021 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
W L Gore & Associates, Inc.
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
| Date | Sep 9, 2020 |
| Status | Open, Classified |
| Reason | 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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 19013 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.