PECTUS SYSTEM PS-1527Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888233027120), received between Jul 21, 2020 and Jul 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED A CUSTOM PECTUS BAR WAS NOT AN IDEAL FIT. THE SURGEON REPORTED THE BAR WAS TOO LONG AND THE BEND WAS OFF. THE BAR WAS ADJUSTED DURING SURGERY AND THE BAR WAS SUCCESSFULLY IMPLANTED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10303173 ↗