Rigid Saddle Ring RSAR-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067044730), received between Mar 23, 2023 and Apr 7, 2023 — 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.

• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_985 - ARB PMCF. DE4432 - 478 (R744179301). IT WAS REPORTED THAT ON (B)(6) 2022 THAT A 34MM RIGID SADDLE RING WAS IMPLANTED. ON (B)(6) 2022 AN X-RAY WAS PERFORMED AND REVEALED PNEUMOTHORAX. THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SYMPTOMS. ON (B)(6) 2022 DRAINAGE WAS PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS DISCHARGED AT THE TIME OF REPORT. THE DIRECT CAUSE OF THE PNEUMOTHORAX IS UNKNOWN, BUT THERE IS NO ALLEGATION OF MALFUNCTION AGAINST THE 34MM RIGID SADDLE RING OR PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 16704904 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_985 - ARB PMCF, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 34MM RIGID SADDLE RING WAS IMPLANTED INTO A PATIENT. ON (B)(6) 2023, ELEVATED GLUCOSE LEVELS WERE OBSERVED AND MEDICATION WAS ADMINISTERED. THE PATIENT IS REPORTED TO BE DISCHARGED.

  Patient problems: Headache; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16606321 ↗