CELERITY 2D 85Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04035479143268), received between Dec 11, 2019 and Jul 22, 2020 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “High Capture Threshold” (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. How this data works · Data updated Oct 16, 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.

• DeathJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIVANOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: ON (B)(6) 2017, PATIENT PRESENTED 2 WEEKS STATUS-POST RIGHT TOE/FOOT RESECTION COMPLAINING OF RIGHT FOOT PAIN, ERYTHEMA AND SWELLING. FOOT CULTURE (B)(6) FOR (B)(6). TREATMENT PLAN PER INFECTIOUS DISEASE. ON (B)(6) 2017, PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH WORSENING SHORTNESS OF BREATH, LOWER EXTREMITY EDEMA AND ASCITES. BLOOD CULTURES (B)(6) FOR (B)(6) ON (B)(6) 2017, AND (B)(6) 2017. TREATED WITH INTRAVENOUS DAPTOMYCIN. RIGHT FOOT NOW CONSISTENT WITH OSTEOMYELITIS. ON (B)(6) 2017, DEVICE SITE WAS ERYTHEMOUS. DEVICE AND THREE LEADS WERE EXTRACTED ON (B)(6) 2017. TISSUE SHOWED EVIDENCE OF INFECTION (B)(6) FOR (B)(6). ON (B)(6) 2018, FOLLOWING SIX WEEKS OF OUTPATIENT DAPTOMYCIN, BLOOD CULTURE FROM (B)(6) 2018 WAS (B)(6) FOR (B)(6). SWITCHED TO INTRAVENOUS VANCOMYCIN. PATIENT NEVER FULLY RECOVERED FROM SYSTEMIC (B)(6) INFECTION AND EVENTUALLY PASSED AWAY.

  Patient problems: Death; Unspecified Infection

  MAUDE report 10311375 ↗
• MalfunctionDec 11, 2019High Capture Threshold; High Capture Threshold

  THIS LEAD WAS CAPPED DUE TO VERY HIGH LV THRESHOLDS CAUSING DEVICE BATTERY DEPLETION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9452130 ↗