MAUDE Adverse Event Report: LIVANOVA USA, INC. RAP FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	200-150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ecmo [extracorporeal membrane oxygenation] cannula readjustment.During cannula readjustment, air entered the line and the cannulas were clamped causing further damage to the line.It has been noted perfusion has had recent issues with these cannulas leaking at the connection ports.Please note that it is undetermined if this is an actual product issue or user error.Cannula described has been returned to the sales rep for analysis.

• Brand Name: RAP FEMORAL VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 24589345
• Report Number: 24589345
• Device Sequence Number: 9193973
• Product Code: DWF
• UDI-Device Identifier: 00803622125805
• UDI-Public: (01)00803622125805
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026
• Report Date (Section F): 01/28/2026

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: 200-150
• Device Catalogue Number: 200-150
• Device Lot Number: 2510400157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/28/2026