CARBOMEDICS ORBIS A1-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08022057012470), received between Jan 16, 2018 and Jan 16, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Gradient Increase” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2018Gradient Increase; Gradient Increase

  ON (B)(6) 2017 AN AVR WAS PERFORMED AND AN ORBIS PROSTHETIC HEART VALVE WAS IMPLANTED. WHEN THE PATIENT WAS IN ICU POST-PROCEDURE, THEY EXPERIENCED VENTRICULAR FIBRILLATION. THE PATIENT WAS RETURNED TO THE OPERATING ROOM, AND IT WAS DISCOVERED THAT THERE WAS GREAT RESISTANCE TO THE VALVE LEAFLETS OPENING AND CLOSING. THE DEVICE WAS EXPLANTED, AND A NEW PRODUCT WAS IMPLANTED. THE PATIENT THEN RESTORED SINUS RHYTHM, AND WAS IN ICU UNDER OBSERVATION AT THE TIME THE EVENT WAS REPORTED TO THE MANUFACTURER.

  Patient problems: Ventricular Fibrillation

  MAUDE report 7198399 ↗