MAUDE Adverse Event Report: LIVANOVA USA INC. AORTIC ROOT CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	14 GA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc.Received a report of an aortic root cannula whose luer lock end cap detached from the needle.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
H11: the affected unit was returned to manufacturer for investigation, and the detachment of the plastic luer lock from the metallic needle was confirmed.A visual inspection revealed no evidence of damage or fracture to either the connector or the metal needle.The presence of solvent was confirmed inside the plastic connector.Based on complaints database analysis, no further events have been reported regarding this same lot, nor concerning trend has been detected.Based on investigation findings, the most likely root cause of the reported event is an isolated manufacturing deviation, specifically an inadequate connection between the connector and the needle, likely due to insufficient insertion of the needle into the connector.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: AORTIC ROOT CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: annarita di lascio ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 23556413
• Report Number: 1718850-2025-90009
• Device Sequence Number: 18672714
• Product Code: DWF
• UDI-Device Identifier: 00803622103094
• UDI-Public: (01)00803622103094(240)AR-17014(17)280218(10)2504900008
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 14 GA
• Device Catalogue Number: AR-17014
• Device Lot Number: 2504900008
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown