EXCOR® C80G-021mRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04260090041352), received between Aug 30, 2019 and Aug 18, 2026 — classified as 1 death, 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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.

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.

• MalfunctionAug 18, 2026Material Discolored

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50301758 ↗
• MalfunctionApr 9, 2026Fracture

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) VIA EMAIL ON (B)(6) 2026 TO REPORT THAT THE OUTFLOW EXCOR ARTERIAL CANNULA PRESENTED WITH A PARTIAL TEAR. PER THE SITE CONTACT, THE PERFUSIONIST WAS INSPECTING THE CANNULAS AND THE PARTIAL TEAR IN THE CANNULA WAS NOTICED. NO BLOOD WAS NOTED TO BE LEAKING FROM THE PARTIAL TEAR. OF NOTE, THIS PATIENT IS ON CONTINUOUS FLOW, AS OF (B)(6) 2026, UTILIZING A EXCOR CONNECTING SET Ø 6/9 MM ON THE OUTFLOW CANNULA AND A 9/9 MM ON THE INFLOW CANNULA. PER THE SITE, THE PATIENT IS PLACED IN THE PRONE POSITION AS WELL AS UPRIGHT IN A CHAIR ON A REGULAR BASIS FOR PHYSICAL THERAPY. IN THE PICTURE PROVIDED BY THE SITE, THE CABLE TIE IS POSITIONED APPROPRIATELY. IT IS IMPORTANT TO NOTE THAT THIS SITE DOES NOT USE THE CABLE TIES SUPPLIED FROM THE MANUFACTURER, AND HAS BEEN RE-EDUCATED MULTIPLE TIMES ON THE RECOMMENDATIONS, WHILE CONTINUING TO USE AN ALTERNATIVE PRODUCT. PRIOR TO NOTIFYING BHI CA, THE SITE REMOVED THE PORTION BELOW THE PARTIAL TEAR AND PUSHED THE CANNULA ONTO THE 6/9 CONNECTING SET. PER THE SITE, THERE IS NOT MUCH DISTANCE FROM THE VELOUR TO THE END OF THE CANNULA BUT ARE UNABLE TO MEASURE AT THIS TIME DUE TO THE OCCLUSIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831198 ↗
• MalfunctionFeb 23, 2026Material Frayed

  THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) VIA EMAIL ON 2026-01-26 TO REPORT THAT ON (B)(6) 2026 AN EXCOR ARTERIAL CANNULA FOR SMALL CHILDREN (LOT 00156523) WAS FRAYED NEAR THE CONNECTION AREA OF THE EXCOR BLOOD PUMP. THE BHI CA CONTACTED THE SITE TO RECOMMEND THAT THE DAMAGED PORTION OF THE AFFECTED CANNULA BE TRIMMED OFF. THE SITE WAS INFORMED TO KEEP THE REMOVED PORTION OF THE CANNULA TO RETURN TO BERLIN HEART FOR FURTHER INVESTIGATION. THE BERLIN EXCOR BLOOD PUMP FUNCTIONED AS INTENDED, MAINTAINING COMPLETE FILLING AND EJECTION THROUGHOUT. ON 2026-02-10, BHI CA FOLLOWED UP WITH THE SITE ABOUT THE PATIENT, WHEREIN THE SITE INFORMED BERLIN HEART THAT THE SURGEON DECIDED NOT TO TRIM THE AFFECTED SECTON OF THE CANNULA, AND THAT THEY PLACED A SECOND CABLE TIE ON THE CANNULA TO REINFORCE THE AREA. AS A RESULT, BHI CA INSTRUCTED THE SITE TO MONITOR THE PATIENT FOR ANY FURTHER COMPLICATIONS, AND THAT THEY RETURN THE AFFECTED PORTION OF THE CANNULA WHEN IT IS TRIMMED, OR THE PATIENT REACHES AN OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414610 ↗
• DeathSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025 THE SITE CONTACTED BERLIN HEART INC. (BHI) CLINICAL AFFAIRS (CA) TO REPORT A CANNULA DISCONNECTION IN A PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC LVAD. THE ARTERIAL CANNULA SEPARATED FROM THE CONNECTING SET THAT WAS CONNECTED TO THE OUTFLOW LIMB OF THE BLOOD PUMP RESULTING IN EXSANGUINATION AND DEATH OF THE PATIENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH EXCOR ARTERIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM. ACCORDING TO THE INFORMATION PROVIDED BY THE SITE, THE PATIENT WAS SITTING UP IN BED AFTER A DIAPER CHANGE WHEN SHE BECAME AGITATED. THE PATIENT "LET OUT A SCREAM, AND THE ARTERIAL CANNULA POPPED OFF OF THE TITANIUM CONNECTOR OF THE 6-9 CONNECTING SET". THE CANNULAS WERE IMMEDIATELY CLAMPED, AND THE PATIENT WAS RESUSCITATED AND PLACED ON ECMO USING THE BERLIN HEART CANNULAS. ONCE ON ECMO, THE SITE REPORTED THAT THEY WERE UNABLE TO ACHIEVE ADEQUATE ECMO FLOWS, AND CARE WAS EVENTUALLY WITHDRAWN. THE SURGEON REPORTED THAT THIS WAS A "CANNULA DISCONNECTION FROM THE 6-9 CONNECTOR, AND NOT A BREACH OF THE CANNULA ITSELF." ON EXAMINATION OF THE CANNULA AND CONNECTING SET PERFORMED AFTER THE EVENT, THERE WERE NO ROUGH EDGES OR EVIDENCE OF TEARING ON THE CANN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23064314 ↗
• MalfunctionJul 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON 2025-07-17, BERLIN HEART GMBH CLINICAL AFFAIRS (CA) WAS INFORMED BY THE JAPANESE DISTRIBUTOR THAT THE CLINIC FOUND A SMALL DROP OF BLOOD LEAKAGE AND CONSEQUENTLY FOUND DAMAGE TO THE EXCOR ARTERIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM. A SMALL CRACK WAS NOTED ON THE OUTFLOW CANNULA BETWEEN THE END OF THE TITANIUM CONNECTOR AND THE CABLE TIE. DUE TO THIS ISSUE, THE PUMP WAS REPLACED AND THE AFFECTED SECTION OF THE CANNULA WAS TRIMMED. THE PATIENT WAS VERY ACTIVE, AND THE CONNECTION BETWEEN THE PUMP AND THE CANNULA WAS BENT FREQUENTLY. THE OUTFLOW CANNULA WAS SLIGHTLY LONGER THAN THE INFLOW CANNULA. THROUGHOUT THE EVENT THE PATIENT REMAINED HEMODYNAMICALLY STABLE WITH NO SIGNIFICANT CLINICAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676227 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  BERLIN HEART INC. CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC ON 2024-07-29 THAT THERE HAD BEEN A CRACK ON THE ARTERIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM ON (B)(6) 2024. THE DEFECT APPEARED TO BE AT THE CANNULA CONNECTION. BLOOD WAS NOTICED ON THE FLOOR. BOTH INFLOW AND OUTFLOW CANNULA WERE CLAMPED AND THE PATIENT WAS INTUBATED. AT THE TIME OF THE REPORT, THE AFFECTED PORTION OF THE CANNULA HAD BEEN TRIMMED OFF AND DISCARDED BY THE SITE, AND NO PHOTOS OF THE CRACK WERE TAKEN. THE PATIENT RECOVERED IN THE ICU AFTER THE EVENT WITH NO DEFICITS NOTED. AT THE TIME OF THE REPORT, THE AFFECTED CANNULA HAD BEEN DISPOSED OF BY THE SITE, AND NO PHOTOS OF THE CRACK WERE TAKEN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20033732 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BERLIN HEART GMBH CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC THAT A PATIENT HAD AN ISCHEMIC STROKE ON (B)(6) 2023. THE CANNULA WASHOUT WAS DONE AND THE CONNECTOR SET WAS EXCHANGED DUE TO FIBRIN DEPOSITS AT THE SAME DAY. CT SCAN RESULT SHOWED ACUTE AND SUBACUTE R) INFARCTIONS, SOME RESIDUAL LLL WEAKNESS. AFTER REVIEWING THE INFORMATION RELATED TO THIS AE, IT WAS DECIDED TO REPORT ON 01/29/2024.

  Patient problems: Ischemia Stroke

  MAUDE report 18695936 ↗
• MalfunctionDec 20, 2023Fracture; Fracture

  BERLIN HEART CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC ON (B)(6) 2023 THAT A SMALL CRACK ON THE OUTFLOW CANNULA WAS DETECTED. THE SURGEON CUT OFF THE DAMAGED CANNULA END AND CONNECTED THE NEW PUMP FOR SAFETY REASON. THE PATIENT WAS CLINICALLY STABLE AND HAD NO NEGATIVE EFFECTS DUE TO THE INCIDENT. NO PICTURE OF THE CANNULA IN QUESTION WAS TAKEN AND THE CANNULA END TRIMMED WAS DISCARDED BY THE CLINIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18368334 ↗
• MalfunctionDec 14, 2023Fracture; Fracture

  BERLIN HEART WAS INFORMED BY THE CLINIC ON 2023-12-05 THAT A CANNULA BREACH ON A PATIENT SUPPORTED IN BVAD CONFIGURATION. THE BREACH OCCURRED ON (THE LVAD), THE LEFT OUTFLOW CANNULA ABOVE THE CABLE TIE. THE BREACHED CANNULA WERE CLAMPED AND LEFT BERLIN HEART BLOOD PUMP (LVAD) WAS DISCONNECTED. THE PATIENT RECEIVED CPR AND WAS TRANSFERRED TO ICU AND CONNECTED TO ECMO ON THE LEFT SIDE. THE RIGHT SIDE WAS STILL SUPPORTED WITH THE BERLIN HEART BLOOD PUMP. THE PATIENT IS STILL SEDATED AND UNDER STRICT OBSERVATION. CT SCAN SHOWED NO BRAIN INJURY. LUNG OF THE PATIENT IS NOT WORKING APPROPRIATE SINCE THE EVENT. NOTE: DURING A ROUTINE INSPECTION, A DEFECT ON THE OUTER SURFACE OF THE SAME CANNULA WAS FOUND EARLIER ON 2023-09-07. HOWEVER, NO BREACH OCCURRED. IN THIS CASE, THE CANNULA WAS SHORTENED AS A PRECAUTIONARY MEASURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325579 ↗
• MalfunctionJun 5, 2023Fracture; Fracture

  BERLIN HEART CLINICAL AFFAIRS WAS INFORMED ON (B)(6) 2023 THAT THE CLINIC IN COPENHAGEN DETECTED A CRACK IN THE CANNULA. CLINICAL AFFAIRS RECOMMENDED SHORTENING OF THE CANNULA AND REQUESTED TO RETURN THE CUT PIECE FOR INVESTIGATION. THE SITE SHORTENED THE CANNULA ON (B)(6) 2023. THE PATIENT WAS NOT NEGATIVELY AFFECTED DURING THE INCIDENT AND THEREAFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056939 ↗
• MalfunctionAug 30, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  WE WERE CONTACTED BY THE CLINIC VIA THE HOTLINE REGARDING A ADVERSE EVENT INVOLVING AN EXCOR PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE CLINIC REPORTED AN AIR EMBOLISM IN THE PATIENT. CONSEQUENTLY, THE PATIENT SUFFERED AN EXTENSIVE HYPOXIC BRAIN INJURY AND VAD SUPPORT WAS WITHDRAWN ON (B)(6) 2019.

  Patient problems: Air Embolism; Death

  MAUDE report 8950605 ↗

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, 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