Truliant 02-022-45-1515Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862305701), received between Jul 24, 2020 and Jul 24, 2020 — classified as 1 malfunction.

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.

• MalfunctionJul 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FEMALE, AGE AND WEIGHT UNKNOWN. ON THE BACK TABLE, DURING THE TIME WE WHERE OPENING THE IMPLANTS AND HAVING THE CIRCULATOR DROP THEM ON THE BACK TABLE. WE HAD A INCIDENT, A PIECE OF THE STICKER LABEL STUCK TO THE OUTER STERILE BOX. WHEN CIRCULATOR OPENED IT. THAT SMALL PIECE OF THE STICKER CAME OFF AND FELL ON THE STERILE FIELD. THE TECH SEEN IT ON THE STERILE PICKED IT UP NOT KNOWING WHERE IT CAME FROM. SHE PROCEEDED TO HAND IT OFF WHY WE WHERE FIGURING OUT. BY THE TIME WE REALIZED IT THE TECH HAD TOUCHED THE IMPLANT. THIS CAUSED A 5-15 MINS DELAY. THERE WAS NO PROBLEMS DO TO THE DELAY. PATIENT WAS FINE

  Patient problems: No Information

  MAUDE report 10324159 ↗