HVAD Pump Implant Kit 1103 (UDI 00888707000062)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888707000062), received between Jul 3, 2017 and Mar 15, 2019 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 15, 2019Biocompatibility; Biocompatibility

  THIS PT HAS A HEARTWARE LVAD (IMPLANTED (B)(6) 2015, AND (B)(6) 2016). PT PRESENTED TO THE EMERGENCY DEPT ON (B)(6) 2019 FOR INCREASED LVAD POWER. HE REPORTS DARK COLORED URINE THAT DEVELOPED RECENTLY AS WELL AS NOTICING INCREASING VOLTAGE ON HIS LVAD FROM A BASELINE OF 7 TO OVER 9 VOLTS. AFTER ADMISSION HE WAS STARTED ON HIGH DOSE HEPARIN PER LVAD THROMBUS PROTOCOL. INTEGRILIN WAS NOT GIVEN DUE TO THROMBOCYTOPENIA. CT SURGERY WAS CONSULTED AND DID NOT FEEL HE WOULD BE A CANDIDATE FOR ANY INTERVENTION OR LVAD EXCHANGE GIVEN HIS POOR TOLERANCE OF HIS LAST EXCHANGE AND MULTIPLE COMORBIDITIES. HE WAS PUT IN A NICARDIPINE DRIP FOR CONTROL OF HIS BP WITH ANTICOAGULATION. HEMATOLOGY WAS CONSULTED WITH REGARDS TO HIS POLYCYTHEMIA AND FELT IT WAS MOST LIKELY SECONDARY TO CHRONIC HYPOXEMIA. HE CONTINUED TO HEMOLYZE AND DID NOT IMPROVE ON HEPARIN ALONE, SO HE WAS GIVEN A DOSE OF TPA, WHICH RESULTED IN SOME IMPROVEMENT IN HIS LVAD WATTAGE FROM 9 TO APPROX 7.7. HOWEVER, HE BECAME ANURIC AND DEVELOPED ACUTE RENAL FAILURE. HE MET WITH THE PALLIATIVE TEAM AND MADE IT CLEAR HE DID NOT WANT DIALYSIS. AFTER SOME DISCUSSION WITH HIS SON, HE DECIDED TO GO HOME ON HOSPICE GIVEN THAT HE HAD LIMITED FUTU

  Patient problems: Death; Hematuria; Hemolysis

  MAUDE report 8433084 ↗
• InjuryJul 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE CLINICAL STUDY SITE THAT THE PATIENT WAS ADMITTED ON (B)(6) 2017 FOR UPPER GASTROINTESTINAL (GI) BLEEDING AND BACTERIA GI INFECTION WITH A URINARY TRACT INFECTION. PATIENT WAS STATED TO HAVE BEEN TRANSFUSED 5 UNITS OF PACKED RED BLOOD CELLS (PRBC'S). PATIENT WAS ALSO STATED TO HAVE RECEIVED ANGIECTASIA CLIPPING, MEDICATION MANAGEMENT, AND ANTIBIOTICS. PATIENT WAS STATED TO HAVE BEEN DISCHARGED ON (B)(6) 2017. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection; Blood Loss; Urinary Tract Infection

  MAUDE report 6684065 ↗