MAUDE Adverse Event Report: Merit Medical Systems, Inc. AERO®; Prosthesis, Tracheal, Expandable

Catalog Number	90129-207/G
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction

• Brand Name: AERO®
• Common Device Name: Prosthesis, Tracheal, Expandable
• Manufacturer (Section D): Merit Medical Systems, Inc.; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): Merit Medical Systems, Inc.; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: lisa perz msn, rn, pmp ; 1600 merit parkway; south jordan, UT 84095 ; +1(801)208-4225
• MDR Report Key: 50794649
• Report Number: 3010665433-2026-00019
• Device Sequence Number: 13390810
• Product Code: JCT
• UDI-Device Identifier: 00884450703984
• UDI-Public: 00884450703984
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 90129-207/G
• Device Lot Number: E3312399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown