MAUDE Adverse Event Report: Heartflow, Inc. Heartflow Analysis

Model Number	4.x
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction

• Brand Name: Heartflow Analysis
• Common Device Name: Heartflow Analysis
• Manufacturer (Section D): Heartflow, Inc.; 135 main street; suite 1000; san francisco CA 94105 -190
• Manufacturer (Section G): Heartflow, Inc.; 135 main street; suite 1000; san francisco CA 94105 -190
• Manufacturer Contact: avelina alvarado ; 135 main street; suite 1000; san francisco, CA 94105--190 ; +1(650)241-1221
• MDR Report Key: 50822565
• Report Number: 3021637148-2026-00018
• Device Sequence Number: 21502219
• Product Code: PJA
• UDI-Device Identifier: 00853341006701
• UDI-Public: (01)00853341006701(10)HFA_4.7.0.3(11)2026-08-07
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K250902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 4.x
• Device Lot Number: HFA_4.7.0.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown