Ellipse™ CD1275-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734506021), received between Jun 10, 2019 and Jun 20, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING REMOTE FOLLOW-UP, AN EGM WAS OBSERVED TO BE MISSING AFTER THE DEVICE DELIVERED APPROPRIATE HIGH VOLTAGE THERAPY. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164389 ↗
• MalfunctionFeb 5, 2021Incorrect Measurement; Incorrect Measurement

  DURING A REMOTE FOLLOW-UP, INCORRECT MEASUREMENTS WERE NOTED ON THE ELECTROMYOGRAPHY. TECHNICAL SUPPORT WAS CONTACTED, HOWEVER, COULD NOT PROVIDE FURTHER EXPLANATION FOR THE EVENT. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11286169 ↗
• MalfunctionJun 10, 2019Battery Problem; Battery Problem

  DURING A FOLLOW-UP, UPON INTERROGATION, A LONGEVITY ANOMALY ON THE DEVICE WAS NOTED. PREMATURE DEPLETION IS SUSPECTED. THE DEVICE REMAINS IMPLANTED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8683156 ↗