EXCOR® A09-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04260090040171), received between Oct 27, 2025 and Apr 13, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (H100004, 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Scratched Material

  THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS VIA PHONE ON (B)(6) 2026 AND PROVIDED A PHOTO TO INQUIRE ABOUT A CIRCUMFERENTIAL INTERNAL SCRATCH OBSERVED ABOVE THE TITANIUM CONNECTOR ON EXCOR CANNULA EXTENSION SET Ø 9/9 MM. THE SITE REPORTED THAT THE CANNULA LENGTH HAD NOT BEEN SHORTENED SINCE REMOVAL FROM THE PACKAGING. THE TITANIUM CONNECTORS WERE NOTED TO HAVE THE APPROPRIATE DISTANCE BETWEEN THEM AND WERE THE SAME LENGTH AS THE OUTFLOW CANNULA CONNECTOR, APPEARING SYMMETRICAL. BERLIN-PROVIDED CABLE TIES WERE APPLIED PER THE IFU, AND NO PREVIOUS DAMAGE HAD BEEN OBSERVED. THE SITE REPORTED THAT THE SCRATCH WAS NEWLY OBSERVED. AT THE TIME OF THE REPORT, THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND THE EXCOR BLOOD PUMP CONTINUED TO FUNCTION AS INTENDED, MAINTAINING FULL FILL AND EJECTION THROUGHOUT. THE SITE CONTACTED BHI CA TO REPORT THAT THE SURGEON WILL CONTINUE MONITORING THE AFFECTED AREA OF THE CANNULA EXTENSION, DESPITE BHI CA'S RECOMMENDATION TO PROCEED WITH AN EXCHANGE. BHI CA EDUCATED THE SITE CONTACT ON THE IMPORTANCE OF CLOSE MONITORING OF THE AFFECTED CANNULA EXTENSION AND RECOMMENDED PLACEMENT OF PERFUSION TUBING OVER THE CANNULA EXTENSION TO PROVIDE ADDITIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866517 ↗
• MalfunctionMar 3, 2026Scratched Material

  THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS ON (B)(6) 2026 TO REPORT AN "EXTERNAL SCRATCH" OBSERVED ON EXCOR CANNULA EXTENSION SET Ø 9/9 MM PARALLEL TO THE TITANIUM CONNECTOR OF THE RVAD INFLOW CANNULA. THE SITE REPORTED THE SCRATCH TO BE A NEW FINDING AS IT WAS NOT PRESENT THE PREVIOUS DAY. THE SITE ALSO REPORTED THAT THE SILICONE FEELS SEPARATED DESPITE THE TUBE BEING INTACT. THE SITE IS UNAWARE HOW THIS SCRATCH OCCURRED. ON THE SAME DAY, THE PATIENT UNDERWENT A BLOOD PUMP AND AN EXTENSION SET EXCHANGE WITHOUT INCIDENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THE EXCOR BLOOD PUMP CONTINUED TO FUNCTION AS INTENDED, MAINTAINING FULL FILL AND EJECTION THROUGHOUT. AT THE TIME OF THE EVENT, ALL THE CANNULA AND CONNECTOR LENGTHS, AS WELL AS THE DISTANCE BETWEEN TITANIUM CONNECTORS, WERE SYMMETRICAL AND WITHIN THE RECOMMENDATIONS OUTLINED IN THE IFU. EXCOR CABLE TIES WERE POSITIONED PER IFU. NO PRIOR DAMAGE OR MODIFICATIONS TO THE CANNULAS OR CONNECTOR SETS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24502980 ↗
• MalfunctionNov 26, 2025Scratched Material; Scratched Material

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON (B)(6) 2025 TO REPORT A CONCERN FOR INTERNAL SCRATCHES ON AN EXCOR CANNULA EXTENSION SET, A09-009 ON THE PATIENT BEING SUPPORTED IN LVAD CONFIGURATION ON THE EXCOR IKUS DRIVING UNIT. UPON REVIEWING THE PICTURE AND VIDEOS PROVIDED BY THE SITE, BHI CA RECOMMENDED THE IMMEDIATE EXCHANGE OF THE AFFECTED EXTENSION SET. OF NOTE, THE EXTENSION SET IN THE IMAGE AND VIDEOS ARE NOTED TO BE SHORTER THAN THE RECOMMEND LENGTH. BHI CA ADVISED THE SITE TO ENSURE ADEQUATE LENGTH OF THE EXTENSION WHEN CHANGED. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED, MAINTAINING COMPLETE FILLING AND EJECTION THROUGHOUT. THE PATIENT HAD NO HARM DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658434 ↗
• MalfunctionOct 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON 2025-10-05 TO REPORT A CANNULA BREACH THAT HAD OCCURRED ON THE PATIENT BEING SUPPORTED WITH EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE IN BIVAD CONFIGURATION. ACCORDING TO THE SITE, THE PATIENT WAS SITTING UP IN BED, COUGHED, AND BLOOD STARTED COMING OUT OF THE RVAD OUTFLOW EXCOR CANNULA EXTENSION SET, A09-009 JUST ABOVE THE TITANIUM CONNECTOR OF THE BLOOD PUMP. THE NURSE PINCHED THE CANNULA, THE OUTFLOW CANNULA WAS CLAMPED, AND THE EXTENSION SET WAS CHANGED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT AND CONTINUES AT THEIR NEUROLOGICAL BASELINE. AT THE TIME OF THE REPORT, THE 9-9 EXTENSION IN QUESTION HAD ALREADY BEEN DISPOSED OF AND NO PICTURES WERE AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23413903 ↗
• MalfunctionOct 27, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CLINIC CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) ON 2025-10-01 TO REPORT A CONCERN FOR A INTERNAL "SCRATCH OR DEFECT" IN THE EXCOR CANNULA EXTENSION SET ON THE RVAD INFLOW SIDE ON A PATIENT WITH EXCOR BI-VAD CONFIGURATION. ACCORDING TO THE CLINIC, THEY WERE UNSURE IF IT WAS A DEFECT OR A SHADOW BUT WERE CONCERNED FOR THE POSSIBILITY OF A DEFECT DUE TO THE ACTIVITY OF THE CHILD. BHI CA REVIEWED THE IMAGE AND RECOMMENDED A PUMP CHANGE ALONG WITH THE CHANGE OF THE SEGMENT OF THE EXTENSION SET. BHI CA ALSO RECOMMENDED THAT THE SEGMENT OF THE EXTENSION SET IN QUESTION BE RETURNED FOR FURTHER EVALUATION. THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION THROUGHOUT. ON 2025-10-02, THE CLINIC NOTIFIED THAT AN EXTENSION SET CHANGE HAD OCCURRED. ACCORDING TO THE CLINIC, THE SEGMENT OF THE EXTENSION IN QUESTION WAS DISPOSED OF. THE PATIENT TOLERATED THE EXTENSION SET CHANGE WITH NO UNTOWARD EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23394517 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H100004, P160035. One submission often covers many models, so check the product and lot details in each record.

• Z-2320-2026 · Apr 24, 2026 · Open, Classified
  EXCOR 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 · Terminated
  EXCOR 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