Recall Z-0998-2023 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Bolton Medical Inc.
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
| Date | Jan 19, 2023 (initiated Dec 20, 2022) |
| Status | Open, Classified |
| Reason | The product may be shorter than packaging indicates |
| Root cause | Labeling Change Control |
| Action | On 12/15/2022, Terumo Aortic/Bolton Medical, Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees by mail. The notice explained the problem and the risk, and requested the return of the device to a Terumo Sales Representative. |
| Quantity | 640 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.