ChronOS 710.026.97SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982255600), received between Sep 2, 2022 and Sep 6, 2022 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, CHRONOS(TM) GRANULES-LRG 2.8-5.6/10 CC-S HAD ENTRY ERRORS AND HAS BEEN ASSOCIATED WITH AN ADVERSE EVENT. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE CHRONOS(TM) GRANULES-LRG 2.8-5.6/10 CC-S. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 15362230 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, IN ACCORDANCE WITH THE JOINT COMMISSION STANDARDS TS.03.01.01, TS.03.02.01, AND TS.03.03.01 (FOR MORE INFORMATION ON THESE THE JOINT COMMISSION STANDARDS, HTTP://WWW.JOINTCOMMISSION.ORG/), THIS WAS INFORMED THAT THE CHRONOS GRANULES LARGE 10CC HAS BEEN ASSOCIATED WITH AN ADVERSE EVENT. THIS REPORT IS FOR ONE (1) CHRONOS(TM) GRANULES-LRG 2.8-5.6/10CC-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 15352671 ↗