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U.S. Department of Health and Human Services

Class 2 Device Recall Aerin Medical VivAer Stylus

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 Class 2 Device Recall Aerin Medical VivAer Stylussee related information
Date Initiated by FirmNovember 12, 2024
Date PostedJanuary 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0808-2025
Recall Event ID 95832
510(K)NumberK200300 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductAerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Code Information Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235
FEI Number 3011625895
Recalling Firm/
Manufacturer		 Aerin Medical, Inc.
232 E Caribbean Dr
Sunnyvale CA 94089-1007
For Additional Information ContactShannon Scott
512-221-9956
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 production lot, they are to return them to the recalling firm, and return instructions are provided. Regarding the mailed "URGENT: MEDICAL DEVICE FIELD NOTICE" letters dated 11/20/2024, they informed the consignee that some of the units in the production lot were programmed incorrectly and, in these cases, the programmed treatment time will be 12 seconds of radiofrequency energy delivery with no cooling time, not the 30 second treatment time for VivAer that includes 18 seconds of energy delivery and 12 seconds of cooling time. The letter also contains instructions to share this notification with all device users within their facility and network to ensure they are aware of this issue. This notification should also be shared with any organization where the potentially affected devices have been transferred. If you need any further information or support concerning this notification, please contact us at customerservice@aerinmedical.com or call 512-221-9956.
Quantity in Commerce479 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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