Skip to content

ECLIPSE PISTON 468-450Recalls & reported problems

Grace Medical, Inc. · ECLIPSE PISTON 0.6MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844505002011), received between Jul 2, 2020 and Jul 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Twisted/Bent1

Patient problems

  • Inadequate Pain Relief1

Recent adverse event reports

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

  • InjuryJul 2, 2020Material Twisted/Bent

    IT WAS REPORTED THAT THE SURGEON PLACED THE PROSTHESIS SUCCESSFULLY SEVERAL MONTHS AGO. AT LEAST WEEKS/MONTHS LATER AT FOLLOW UP APPOINTMENT, PATIENT HAD MENTIONED TO THE SURGEON THAT THEIR HEARING HAD NOT IMPROVED. AFTER MONTHS OF NO IMPROVEMENT THE PHYSICIAN DECIDED TO GO IN AND INVESTIGATE. WHEN THE PHYSICIAN OPENED UP THE PATIENT, HE FOUND THE SHAFT BENT. THE SURGEON DECIDED TO PLACE ANOTHER PROSTHESIS TO RESTORE THE PATIENT'S HEARING.

    Patient problems: Inadequate Pain Relief

    MAUDE report 10227374 ↗

Other PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT devices

All PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.