MAUDE Adverse Event Report: LIVANOVA DEUTCHLAND EVO CLAMP; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	ELCTRNC VENOUS OCCLDR UNIT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 to a5: patient information was not provided.D4: the serial number is currently not available.The unique device identifier (udi) number is currently not available.H4/h5: the device manufacturing date is currently not available.H11: livanova has 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 deutschland received a report regarding the error message "occluder 1 is either disconnected or malfunctioning", during service, of an evo clamp occluder.The alarm stopped after turning on and off the device several times.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
D4: serial number provided: (b)(6).Udi: (b)(4).H4: manufacturing date of involved device: 26-jul-2016.H11: complaints database review revealed no similar events since unit¿s installation.Based on the investigation findings, the root cause of the reported event was traced back to a temporary/intermittent internal electrical failure as a false contact or bad connections, which was definitively fixed by service technician throughout the equipment check.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: EVO CLAMP
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LivaNova Deutschland; lindberghstraße 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24636401
• Report Number: 9611109-2026-90098
• Device Sequence Number: 8853007
• Product Code: DWF
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2026

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: ELCTRNC VENOUS OCCLDR UNIT
• Device Catalogue Number: 12-80-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 07/30/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/11/2026; 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2016
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown