EXCOR® C60G-004mRecalls & reported problems
Berlin Heart GmbH · Arterial cannula for children Ø 12/9 mm; L 32 cm; angle 60° · Class 3
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260090041338), received between Jan 2, 2025 and Jan 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (1 report).
2 other recalls cover devices cleared under the same FDA submission (P160035); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2025Scratched Material; Scratched Material
ON (B)(6) 2024 THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT A SCRATCH ON THE OUTFLOW CANNULA AT THE CANNULA-PUMP JUNCTION WITH BLOOD SURROUNDING THE METAL CONNECTOR OF THE PUMP. CA REQUESTED PICTURES OF THE REPORTED CONCERN. UPON REVIEWING THE PICTURES, CA CONFIRMED THE SCRATCH AND THE BLOOD AROUND THE CONNECTION OF THE PUMP. CA RECOMMENDED THAT THE SITE REMOVE THE AFFECTED SECTION OF CANNULA AND REPLACE THE BLOOD PUMP IF NEEDED. DESPITE THE ISSUE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION, THE PATIENT REMAINED STABLE, AND NO SIGNIFICANT CLINICAL COMPLICATIONS WERE REPORTED. ON (B)(6) 2024, THE AFFECTED SECTION OF THE CANNULA WAS TRIMMED, AND THE PUMP WAS EXCHANGED DUE TO THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056769 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P160035. One submission often covers many models, so check the product and lot details in each record.
- Z-2320-2026 · Apr 24, 2026 · Open, ClassifiedEXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
- Z-1618-2023 · May 18, 2018 · TerminatedEXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood
Other Ventricular (Assisst) Bypass devices
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls2,141 deaths8,000 reports
- Thoratec® HeartMate 3™ 106531USThoratec Corporation · Ventricular (Assisst) Bypass1 recall11 deaths4,646 reports
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit (Enhanced) 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls573 deaths2,807 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HEARTMATE®, MOBILE POWER UNIT, NA 107754Thoratec Corporation · Ventricular (Assisst) Bypass1 death2,098 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.