FDA Adverse Event Injury Summary report: N

EXCOR®

MDR report key: 24306086 · Received February 10, 2026

Report

Report Number: 3008454189-2026-00002
Event Type: Injury
Date Received: February 10, 2026
Date of Event: January 8, 2026
Report Date: February 10, 2026
Manufacturer: BERLIN HEART GMBH
Product Code: DSQ
UDI-DI: 04260090040157
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: CO, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, S/N (B)(6) WAS USED ON THE PATIENT FROM (B)(6) 2025 UNTIL THE PUMP WAS EXCHANGED ON 2026-01-20. THE EVENT OCCURRED ON 2026-01-08, WHICH IS (10 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT BEING SUPPORTED WITH AN EXCOR ACTIVE DRIVING UNIT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP. THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS.

Description of Event or Problem · 0

THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS (CA) ON 2026-01-19 TO REPORT THAT ON (B)(6) 2026 A PAN-SCAN CT WAS PERFORMED ON THE PATIENT WITH BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM, S/N (B)(6), FOLLOWING BLOOD STREAM INFECTION AND AN ISCHEMIC CVA WAS INCIDENTALLY FOUND. THE IMAGING WAS MOST CONSISTENT WITH SUBACUTE RIGHT PCA STROKE, NO MOVEMENT OF VISUALIZED FIBRIN AFTER THE EVENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH ONLY CANNULAS ON (B)(6) 2025 AND IS BEING SUPPORTED WITH THE FULL EXCOR SYSTEM SINCE 2025-12-29. SINCE THAT TIME, THE PATIENT HAS BEEN SUFFERED FROM SEVERAL BACTERIAL AND FUNGAL INFECTIONS. THE BERLIN EXCOR BLOOD PUMP FUNCTIONED AS INTENDED MAINTAINING FULL FILL AND EJECT. DEPOSITS WERE NOTED IN THE PUMP BEFORE AND AFTER THE CONFIRMATION OF CVA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
363364	EXCOR®	VENTRICULAR (ASSIST) BYPASS	DSQ	BERLIN HEART GMBH	P15P-001		04260090040157

Patients

Seq	Age	Sex	Outcome	Treatment
1	4 MO	Male	Other