AIRvance® 76353200MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169523265), received between Apr 28, 2017 and Apr 28, 2017 — 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 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTS THAT DURING A POST-OPERATIVE FOLLOW UP AFTER THE IMPLANTATION OF THE DEVICE, THE PATIENT HAD ACQUIRED AN "INCISION INFECTION". THE WOUND WAS DEBRIDED AND THE PATIENT TREATED WITH ANTIBIOTICS. AT THIS TIME, THE PATIENT HAS MADE A "GOOD RECOVERY".

  Patient problems: Post Operative Wound Infection

  MAUDE report 6531865 ↗
• InjuryApr 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTS THAT DURING A POST-OPERATIVE FOLLOW UP AFTER THE IMPLANTATION OF THE DEVICE, THE PATIENT HAD ACQUIRED AN "INCISION INFECTION". THE WOUND WAS DEBRIDED AND THE PATIENT TREATED WITH ANTIBIOTICS. AT THIS TIME, THE PATIENT HAS MADE A "GOOD RECOVERY".

  Patient problems: Post Operative Wound Infection

  MAUDE report 6531861 ↗