Recall Z-0808-2025 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Aerin Medical, Inc.
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
| Date | Jan 6, 2025 (initiated Nov 12, 2024) |
| Status | Open, Classified |
| Reason | Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued emails on 11/12/2024. It was necessary to notify several consignees by mail with an "URGENT: MEDICAL DEVICE FIELD NOTICE" letter dated 11/20/2024. The email described the product purchased by the consignee and the reason for recall. The consignee is informed the programmed treatment time will be shorter than the recommended 30 second treatment time for VivAer and the use of the device may result in insufficient treatment. Under the heading "Action to be Taken," it says if a defective device is identified or the consignee wishes to return unused devices within this |
| Quantity | 479 units |
| Distribution | US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY, NE, NY, OH, OR PA, SC, TN, TX, UT, VA, WA, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200300 | VivAer Stylus Aerin Medical, Inc., Apr 13, 2020 |