EXCOR® C80G-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04260090040393), received between Mar 15, 2017 and Aug 7, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2020Material Puncture/Hole; Material Puncture/Hole

  WE WERE INFORMED BY OUR (B)(6) DISTRIBUTOR ABOUT AN INCIDENT INVOLVING THE ARTERIAL CANNULA OF AN EXCOR PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE DISTRIBUTOR REPORTED THAT A SMALL AMOUNT OF BLOOD WAS EMERGING FROM THE ARTERIAL CANNULA. THE AFFECTED CANNULA WAS SHORTENED BY TRAINED SPECIALIST PERSONNEL IN THE CLINIC AND THE EXCOR BLOOD PUMP WAS REPLACED. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT AND WE WERE INFORMED THAT THE PATIENT IS DOING WELL AFTER THE SHORTENING OF THE CANNULA AND EXCHANGING THE BLOOD PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379777 ↗
• MalfunctionJul 3, 2020Material Puncture/Hole; Material Puncture/Hole

  WE WERE INFORMED BY OUR (B)(6) DISTRIBUTOR ABOUT AN INCIDENT INVOLVING THE ARTERIAL CANNULA OF AN EXCOR PATIENT SUPPORTED IN THE LVAD CONFIGURATION. THE DISTRIBUTOR REPORTED THAT THE ARTERIAL CANNULA HAD A CRACK. THE AFFECTED EXCOR OUTLET CANNULA WAS SHORTENED BY TRAINED SPECIALIST PERSONNEL IN THE CLINIC AND THE EXCOR BLOOD PUMP WAS REPLACED. THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT AND WE WERE INFORMED THAT THE PATIENT WAS WELL AFTER THE SHORTENING OF THE CANNULA AND EXCHANGING THE BLOOD PUMP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10229624 ↗
• MalfunctionAug 10, 2017Material Puncture/Hole; Material Puncture/Hole

  BERLIN HEART (B)(4) WAS INFORMED BY OUR (B)(6) DISTRIBUTOR THAT AN EXCOR BLOOD PUMP PATIENT SUPPORTED IN THE LVAD CONFIGURATION EXPERIENCED MINIMAL BLEEDING AT THE CANNULA EXIT SITE. THE BLEEDING STARTED ON (B)(6) 2017. THE CLINIC SUSPECTED AN INJURY AT THE EXIT SITE AND KEPT THE BLEEDING UNDER OBSERVATION. ON (B)(6) 2017, THE BLEEDING INCREASED PROGRESSIVELY AND THE PATIENT WAS TAKEN TO THE OR URGENTLY FOR SURGICAL EXPLORATION. WHEN THE CHEST WAS OPENED IN THE OR, THERE WAS EXTENSIVE BLOOD LOSS. ONCE THE PATIENT WAS STABILIZED, AN INSPECTION OF THE ARTERIAL EXCOR CANNULA REVEALED A FRACTURE OF THE CANNULA VERY CLOSE TO THE AORTIC ANASTOMOSIS. THE AFFECTED EXCOR CANNULA AND BLOOD PUMP WERE EXCHANGED BY TRAINED PERSONNEL AT THE CLINIC. BERLIN HEART WAS INFORMED OF THE EVENT AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6786403 ↗
• MalfunctionMar 15, 2017Leak/Splash; Leak/Splash

  WE WERE INFORMED BY OUR DISTRIBUTOR IN (B)(4), THAT THE CLINIC NOTED SOME MINIMAL DAMAGE IN THE ARTERIAL CANNULA OF THE RIGHT EXCOR BLOOD PUMP OF A PATIENT SUPPORTED IN THE BVAD CONFIGURATION. A SMALL TEAR WAS IDENTIFIED IN THE SILICON THAT LED TO THE LEAKAGE OF A MINIMAL AMOUNT OF BLOOD. TRAINED PERSONNEL AT THE CLINIC TRIMMED OFF THE COMPROMISED SECTION OF THE CANNULA. THE SITE REPORTED THAT THE PATIENT WAS NOT NEGATIVELY AFFECTED BY THE INCIDENT AND IS DOING WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6405924 ↗

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