RHEAD RCN-S160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886385025131), received between Sep 9, 2015 and Sep 9, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

Recent adverse event reports

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

• InjurySep 9, 2015Device Operates Differently Than Expected

  DUE TO THE REGULATORY ACTION (B)(4), ONE OF THE CUSTOMERS AFFECTED, REPORTED THAT IN THE PAST THEY RECEIVED PRODUCT UNDER THE SCOPE OF THIS ACTION. WHILE PUTTING THEIR RECORDS TOGETHER, THEY NOTICED THAT THERE WAS A PATIENT IMPLANTED WITH ONE OF THESE LOTS THAT WAS RELATED TO AN EVENT OF PATIENT INFECTION. THE PATIENT SUFFERED AN INFECTION AFTER THE IMPLANTATION AND HE WAS EXPLANTED BY (B)(6) 2012. THE HOSPITAL DID NOT REPORT NEITHER THE FORMER DISTRIBUTOR OF (B)(6) NOR THE COMPETENT AUTHORITIES.

  Patient problems: Unspecified Infection

  MAUDE report 5065206 ↗