Recall Z-0290-2021 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 | Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible |
| Root cause | Unknown/Undetermined by firm |
| 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 inability to complete secondary deployment and that the Recalling Firm will be updating it Instruction for Use to include a new Warning: Secondary deployment events have occurred where the device does not open to full diameter after Secondary Deployment Handle actuation, and the deployment line is not accessible via the Deployment Line Access Hatch. If this event occurs, Gore recommends using the GORE Tri-Lobe Bal |
| Quantity | 13860 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.