EXCOR® A06-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04260090040591), received between Apr 8, 2016 and Jan 8, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Scratched Material

  THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT A WHITE LINE THAT WAS NOTED ON THE EXCOR CONNECTING SET FOR CANNULAS Ø 6/9 MM PARALLEL TO THE TITANIUM CONNECTOR OF THE LVAD OUTFLOW CANNULA ON 2025-12-11. BHI CA REVIEWED THE PICTURE PROVIDED BY THE SITE, AND RECOMMENDED THAT THE CONNECTING SET BE CHANGED OR TRIMMED TO REMOVE THE AFFECTED AREA DUE TO A CONCERN FOR POTENTIAL INTERNAL DAMAGE TO THE TUBING. THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED THROUGHOUT, MAINTAINING COMPLETE FILLING AND EJECTION. AT THE TIME OF THE EVENT, ALL LENGTHS OF THE CANNULAS/CONNECTORS AND DISTANCE BETWEEN TITANIUM CONNECTORS WERE SYMMETRICAL AND WITHIN THE RECOMMENDATIONS OF THE IFU. EXCOR CABLE TIES WERE POSITIONED PER THE IFU, AND THERE WERE NO PREVIOUS DAMAGE OR MODIFICATIONS TO THE CANNULAS OR CONNECTOR SETS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012587 ↗
• MalfunctionJan 8, 2026Scratched Material

  THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT REGARDING A WHITE LINE THAT WAS NOTED ON THE EXCOR CONNECTING SET FOR CANNULAS Ø 6/9 MM PARALLEL TO THE TITANIUM CONNECTOR OF THE OUTFLOW CANNULA ON (B)(6) 2025. BHI CA REVIEWED THE PICTURE PROVIDED BY THE SITE AND RECOMMENDED THAT THE CONNECTING SET BE CHANGED OR TRIMMED TO REMOVE THE AFFECTED AREA DUE TO A CONCERN FOR POTENTIAL INTERNAL DAMAGE TO THE TUBING. THE EXCOR BLOOD PUMP FUNCTIONED AS INTENDED THROUGHOUT, MAINTAINING COMPLETE FILLING AND EJECTION. AT THE TIME OF THE EVENT, ALL LENGTHS OF THE CANNULAS/CONNECTORS AND DISTANCE BETWEEN TITANIUM CONNECTORS WERE SYMMETRICAL AND WITHIN THE RECOMMENDATIONS OF THE IFU. THE EXCOR CABLE TIES WERE POSITIONED PER THE IFU, AND THERE WERE NO PREVIOUS DAMAGE OR MODIFICATIONS TO THE CANNULAS OR CONNECTOR SETS NOTED. THE CONNECTING SET WAS EVALUATED AFTER SHORTENING, AND THE INTERNAL ABRASIONS WERE NOTED INSIDE OF THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006451 ↗
• MalfunctionMar 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6)2025, THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) TO REPORT AN ISSUE WITH THE EXCOR CONNECTING SET FOR CANNULAS Ø 6/9 MM (LOT 00140046). THE SITE NOTED THAT BLOOD WAS OBSERVED AROUND THE CANNULA CONNECTION. THE SITE REPLACED THE BLOOD PUMP WITH THE CONNECTING SET WITHOUT ANY COMPLICATIONS. PREVIOUSLY ON (B)(6)2025, THE SITE ALSO REPORTED AN ANOMALY WITH THE SAME CONNECTING SET, WHICH INVOLVED "BULGING OR BUBBLING" WITH BLACK FILM AROUND THE OUTFLOW CONNECTOR. UPON EVALUATION OF THE PICTURES PROVIDED BY THE SITE, CA RECOMMENDED THAT THE SITE CLOSELY MONITOR THE CONNECTOR AND REPORT AGAIN AS SOON AS THERE IS A CHANGE IN ITS APPEARANCE. THROUGHOUT THE EVENT, THE PUMP MAINTAINED COMPLETE FILLING AND EJECTION, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE WITH NO SIGNIFICANT CLINICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657478 ↗
• MalfunctionJul 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE SITE CONTACTED CLINICAL AFFAIRS TO REPORT THAT DURING THE PUMP EXCHANGE FOR UPSIZING, THE 6/9MM CONNECTORS HAD BEEN PLACED ON THE 25ML PUMP, AND AFTER CONNECTING THE OUTFLOW CONNECTOR TO THE OUTFLOW CANNULA THE SURGEON NOTICED BLOOD LEAKAGE FROM THE OUTFLOW CONNECTOR SITE. THE SURGEON REATTACHED THE OUTFLOW CANNULA TO THE CONNECTOR, BUT IT CONTINUED TO LEAK. THE SURGEON USED A DIFFERENT CONNECTOR SET AND ATTACHED IT TO THE OUTFLOW CANNULA WITHOUT ISSUES. THERE WAS NO LONGER A BLOOD LEAKAGE COMING FROM THE OUTFLOW CONNECTOR SITE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424416 ↗
• MalfunctionMar 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  THE SURGEON ON SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS (CA) ON (B)(6) 2023 TO REPORT AN ABNORMALITY ON THE OUTFLOW CANNULA CONNECTING SET. THE PRESENCE OF A "BLEMISH" WAS CONFIRMED BY CA WITH THE SITE'S VAD COORDINATOR. CA SPECIALIST VISITED THE SITE ON THE SAME DAY AND ASSESS THE CONNECTING SET. UPON AN IN-PERSON ASSESSMENT OF THE CONNECTOR, AN APPROXIMATELY 8MM GASH (CUT) WAS NOTED IN THE OUTFLOW 6-9 CONNECTOR JUST ABOVE THE TITANIUM CONNECTOR OF THE PUMP. THE GASH WAS PALPABLE IN THE OUTER SURFACE OF THE CONNECTING SET. THE IMMEDIATE RECOMMENDATION WAS MADE TO EITHER TRIM OFF THE DAMAGED PORTION OF THE CONNECTOR, OR TO CHANGE THE CONNECTOR COMPLETELY. THE DAMAGED PORTION OF THE CONNECTOR WAS REQUESTED TO BE RETURNED TO BHI FOR FURTHER EVALUATION. THE PATIENT REMAINS STABLE AT THE TIME OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495833 ↗
• MalfunctionJul 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BERLIN HEART, GMBH WAS NOTIFIED BY THE SITE THAT DURING A CONNECTING SET CHANGE, A SMALL AMOUNT OF BLOOD ( LESS THAN 2 MLS ) WAS OBSERVED DURING THE FINAL CABLE TIE REMOVAL. THE CONNECTING SET WAS BEING EXCHANGED DUE TO THROMBUS. THE SIDE CUTTERS WERE KEPT IN THE SAME POSITION TO PROVIDE SLIGHT PRESSURE FOR PREVENTION OF FURTHER BLOOD LOSS. A STERILE FIELD WAS PREPARED, THE LVAD BLOOD PUMP WAS PAUSED, AND THE AFFECTED CONNECTING SET WAS EXCHANGED WITHOUT UNTOWARD EFFECT TO THE PATIENT. UPON REMOVAL, A SMALL LONGITUDINAL SLIT WAS SEEN (APPROX. 3 MM) AT THE POSITION OF THE CABLE TIE. OF NOTE, THE CABLE TIES WERE BEING REMOVED WITH THE SIDE CUTTERS. THE CLINIC DISPOSED OF THE EFFECTED CONNECTING SET TUBING, THEREFORE, THE PRODUCT IS NOT AVAILABLE FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014181 ↗
• MalfunctionOct 12, 2016Leak/Splash; Leak/Splash

  THE SITE INFORMED BERLIN HEART CLINICAL AFFAIRS(CA) THAT THERE WAS AN EXCHANGE OF THE CONNECTOR SET FOR CANNULAS AND EXCOR BLOOD PUMP FOR A PATIENT SUPPORTED IN LVAD CONFIGURATION. THE SITE REPORTED THAT A "WHITE SPOT" WAS OBSERVED ON THE CONNECTING SET 24 HOURS PRIOR TO THE EVENT DATE, WHICH BECAME PROGRESSIVELY LARGER. UPON FURTHER INSPECTION, THE CONNECTOR SET TUBING APPEARED TO HAVE A BREACH ON THE INSIDE. THE PUMP PERFORMANCE WAS MAINTAINED AS INTENDED THROUGHOUT THE EVENT. TRAINED PERSONNEL AT THE CLINIC REPLACED THE AFFECTED CONNECTOR SET AND EXCOR BLOOD PUMP. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE EXCHANGE OF THE CONNECTOR SET WELL WITH NO UNTOWARD EFFECT. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6021782 ↗
• MalfunctionSep 15, 2016Leak/Splash; Leak/Splash

  THE MANUFACTURER, BERLIN HEART (B)(4) WERE INFORMED BY OUR (B)(4) DISTRIBUTOR VIA EMAIL, THAT THE HOSPITAL (B)(6) DETECTED A SMALL BREACH IN THE CONNECTING SET TUBING WHICH WAS CONNECTED TO THE LEFT EXCOR BLOOD PUMP ON A PATIENT SUPPORTED IN THE BIVAD CONFIGURATION. THE BREACH WAS NEAR THE TITANIUM CONNECTOR OF THE LEFT EXCOR BLOOD PUMP. THE BREACH WAS MINIMAL AND DID NOT NEGATIVELY IMPACT THE INTENDED CARE OF THE PATIENT. TRAINED PERSONNEL AT THE CLINIC REPLACED THE AFFECTED CONNECTING SET. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE EXCHANGE WELL WITH NO UNTOWARD EFFECT. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5952898 ↗
• MalfunctionSep 15, 2016Leak/Splash; Leak/Splash

  THE MANUFACTURER BERLIN HEART (B)(4) WAS CONTACTED BY THE SITE IN (B)(6) TO REPORT THAT A SMALL BREACH WAS OBSERVED IN THE CONNECTING SET TUBING WHICH WAS CONNECTED TO AN EXCOR BLOOD PUMP ON A PATIENT SUPPORTED IN THE LVAD. THE BREACH IN THE TUBING WAS ABOVE THE EDGE OF THE TITANIUM CONNECTOR ON THE BLOOD PUMP. THE BREACH WAS MINIMAL AND DID NOT NEGATIVELY IMPACT THE INTENDED CARE OF THE PATIENT. TRAINED PERSONNEL AT THE CLINIC REPLACED THE AFFECTED CONNECTOR SET. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE EXCHANGE OF THE CONNECTING SET WELL WITH NO UNTOWARD EFFECT. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5952866 ↗
• MalfunctionApr 29, 2016Leak/Splash; Leak/Splash

  BERLIN HEART CLINICAL AFFAIRS (CA) CALLED THE SITE ON (B)(6) 2016 TO INQUIRE ABOUT A PUMP CHANGED THAT OCCURRED ON (B)(6) 2016 ON A PATIENT SUPPORTED IN LVAD CONFIGURATION. THE SITE STATED THAT THE PUMP WAS CHANGED ON (B)(6) 2016 AT 2100 HOURS DUE TO A LEAK IN THE CONNECTING SET TUBING, WHICH WAS CONNECTED TO OUTFLOW SIDE OF THE PUMP. THE SITE THOUGHT THAT LEAK WAS CAUSED BY THE PATIENT CHEWING ON THE TUBING. ACCORDING TO THE ATTENDING SURGEON, THE NURSES HAVE WITNESSED THE PATIENT CHEWING ON THE CANNULA AND CONNECTOR IN THE PAST. THIS EVENT WAS NOT WITNESSED, HOWEVER, THE EVENING OF THE EVENT A NURSE NOTED BLOOD ON THE OUTSIDE OF THE PUMP AND CONNECTOR AS WELL AS IN THE PATIENT'S MOUTH. A TEGADERM WAS PLACED OVER THE COMPROMISED AREA OF THE CONNECTOR AND AN EMERGENT PUMP CHANGE WAS PERFORMED. THE SITE HAS CHANGED THE CONNECTING SET AS WELL. HOWEVER, SITE HAS DISCARDED THE PUMP AND THE CONNECTING SET. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE PUMP CHANGE WELL, WITH NO UNTOWARD EFFECTS ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5619782 ↗
• MalfunctionApr 8, 2016Leak/Splash; Leak/Splash

  THE SITE CALLED BERLIN HEART CLINICAL AFFAIRS (CA) ON (B)(6) 2016 TO REPORT THAT THE SITE HAD CHANGED THE EXCOR BLOOD PUMP ON A PATIENT SUPPORTED IN LVAD CONFIGURATION, BECAUSE A NURSE NOTICED DROP OF BLOOD ON THE OUTSIDE OF THE CONNECTING SET TUBING WHICH WAS CONNECTED TO OUTFLOW SIDE OF THE PUMP. THE BLOOD DROP WAS, VERY CLOSE TO THE CONNECTING SET TITANIUM CONNECTOR. THE SITE ALSO REPORTED THAT THE BLOOD COULD ONLY BE PRODUCED BY BENDING THE CANNULA AWAY FROM THE SITE OF THE BLOOD. THE SITE HAS REUSED THE CONNECTING SET TUBING, AFTER TRIMMING OFF THE COMPROMISED SECTION OF THE CONNECTOR SET TUBING. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE PUMP CHANGE WELL, WITH NO UNTOWARD EFFECTS ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5563022 ↗

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