EnSite™ ENSITE-FF-ABRKT-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067033550), received between Mar 6, 2026 and Mar 6, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical 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 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.

• InjuryMar 6, 2026Mechanical Problem

  IT WAS REPORTED BY A CLINICAL SPECIALIST THAT WHILE PREPARING THE CATH LAB FOR AN EP PROCEDURE THAT A WORKPLACE INJURY WAS SUSTAINED. WHILE ATTACHING THE MAGNET ONTO THE TABLE, THE BRACKET FOR THE MAGNET STUCK AND WHEN TRYING TO ATTACH IT, THE INDIVIDUAL USED THEIR THUMB TO PRY ON THE TABLE AND THEIR THUMB CRACKED AND BENT BACK. AN ORTHOPEDIC SURGEON WAS CONSULTED. AN MRI SHOWED A PARTIAL TEAR IN THE LIGAMENT. A BRACE WAS RECOMMENDED AND A FOLLOW UP IS PLANNED FOR THE END OF (B)(6).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24533563 ↗