Morpheus 006-MORRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812593020644), received between Sep 15, 2016 and Sep 15, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 15, 2016Insufficient Device Problem Information

  A HOSPITAL REPRESENTATIVE VERBALLY CONTACTED A BIOGENNIX DISTRIBUTOR REQUESTING PRODUCT TESTING AND STERILIZATION INFORMATION ON THREE DIFFERENT MORPHEUS LOTS. THE HOSPITAL WAS PERFORMING A FOLLOW-UP INVESTIGATION ON THREE SEPARATE PATIENT INFECTIONS THAT OCCURRED OVER A PERIOD OF SEVERAL WEEKS FOLLOWING SURGICAL PROCEDURES IN WHICH MORPHEUS WAS USED CONCOMITANTLY WITH OTHER UNDISCLOSED DEVICES. BIOGENNIX ASSESSMENT: DHR REVIEW CONFIRMED THAT MORPHEUS WAS PROVIDED STERILE AND IS UNLIKELY TO CAUSE A CONTAMINATION OR INFECTION. SINCE THE PRODUCT WAS NOT RETURNED AND ADDITIONAL PRODUCT SAMPLES FROM THIS LOT ARE NO LONGER AVAILABLE, WE CANNOT CONDUCT ANY FURTHER INVESTIGATION. ALL UNITS FROM THIS LOT HAVE BEEN IMPLANTED AND NO OTHER ADVERSE REPORTS HAVE BEEN RECEIVED. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Unspecified Infection

  MAUDE report 5953033 ↗