MAUDE Adverse Event Report: Berlin Heart GmbH EXCOR®; Ventricular (Assist) Bypass

Model Number	C80G-021m
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction

• Brand Name: EXCOR®
• Common Device Name: Ventricular (Assist) Bypass
• Manufacturer (Section D): Berlin Heart GmbH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer (Section G): Berlin Heart GmbH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; +1(734)709-2080
• MDR Report Key: 50301758
• Report Number: 3004582654-2026-00037
• Device Sequence Number: 15890569
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: (01)04260090041352(17)280211(10)00152219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: C80G-021m
• Device Lot Number: 00152219
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 16 MO
• Patient Sex: Male
• Patient Weight: 20 LB