MAUDE Adverse Event Report: Inari Medical, Inc. LimFlow Extension Stent Graft, 5.5mm x 200mm; Stent Graft, Infrapopliteal, Venous Arterialization

Model Number	RGS-55200-US-24
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction

• Brand Name: LimFlow Extension Stent Graft, 5.5mm x 200mm
• Common Device Name: Stent Graft, Infrapopliteal, Venous Arterialization
• Manufacturer (Section D): Inari Medical, Inc.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): Confluent Medical Technologies Inc.; coyol free zone; building 28; alajuela 20113 ; CS 20113
• Manufacturer Contact: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; +1(949)413-2147
• MDR Report Key: 50736203
• Report Number: 3023527320-2026-00002
• Device Sequence Number: 10586971
• Product Code: QWN
• UDI-Device Identifier: 00850041730219
• UDI-Public: (01)00850041730219(17)260924(10)82347907
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2026
• Device Model Number: RGS-55200-US-24
• Device Catalogue Number: RGS-55200-US-24
• Device Lot Number: 82347907
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown