PECTUS BLU (TM) 78-6110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888233032636), received between Jul 30, 2025 and Jul 31, 2025 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL NUSS PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY FIVE (5) MONTHS POST-IMPLANTATION DUE TO PAIN. THE STABILIZER BAR WAS REMOVED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22680467 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL NUSS PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AND PLEURAL EFFUSION REQUIRING CHEST TUBE PLACEMENT AND HOSPITALIZATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pleural Effusion; Pneumonia

  MAUDE report 22671837 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL NUSS PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINETEEN (19) MONTHS POST-IMPLANTATION DUE TO PAIN. THE BARS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22671830 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED; THE PATIENT UNDERWENT AN INITIAL NUSS PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY NINETEEN (19) MONTHS POST-IMPLANTATION DUE TO PAIN. THE BARS WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 22671828 ↗