MAUDE Adverse Event Report: Inari Medical, Inc. Triever20 Curve, 20Fr, 105cm; Peripheral Mechanical Thrombectomy With Aspiration

Model Number	21-201
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2026
Type of Reportable Event	Malfunction

• Brand Name: Triever20 Curve, 20Fr, 105cm
• Common Device Name: Peripheral Mechanical Thrombectomy With Aspiration
• Manufacturer (Section D): Inari Medical, Inc.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): Inari Medical, Inc.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; +1(949)413-2147
• MDR Report Key: 50130636
• Report Number: 3020347218-2026-00057
• Device Sequence Number: 5598847
• Product Code: QEW
• UDI-Device Identifier: 00810123710522
• UDI-Public: (01)00810123710522(17)280526(10)26050041
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K231848
• 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,Followup,Followup
• Report Date (Section B): 09/30/2026

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 Model Number: 21-201
• Device Catalogue Number: 21-201
• Device Lot Number: 26050041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/05/2026
• Supplement Date Received by Manufacturer: Not provided; 07/05/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/21/2026; 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 47 YR
• Patient Sex: Male