Force FX Force FX-C ZERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521133921), received between Apr 28, 2026 and Apr 28, 2026 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING MASTECTOMY PROCEDURE, THE TWO UNITS THAT WERE USED AT THE SAME TIME NEEDED AN EVALUATION. PATIENT HAD BRADY HEART RATE. ATROPINE, CHEST COMPRESSIONS (LESS THAN 5 MINUTES) AND EPINEPHRINE WERE REQUIRED TO CORRECT THE BRADYCARDIA. PATIENT HOSPITALIZATION WAS ALSO PROLONGED FOR CARDIAC WORK-UP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Arrhythmia

  MAUDE report 25017388 ↗