PECTUS SYSTEM 01-3714Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841036011048), received between Dec 13, 2020 and Mar 23, 2026 — 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Skin Discoloration

  MAUDE report 24661318 ↗
• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CARDIAC MRI WAS ABANDONED AFTER THE PATIENT EXPERIENCED A BURNING SENSATION AT THE SITE OF THEIR PECTUS SUPPORT BAR. ONE (1) MONTH FOLLOWING IMPLANTATION OF TWO (2) PECTUS SUPPORT BARS, THE PATIENT WENT IN FOR A CARDIAC MRI. THE PATIENT FELT SOME HEATING AFTER THE FIRST LOCALIZER. SOME OTHER QUICKER LOCALIZERS THAT PRODUCE LESS SPECIFIC ABSORPTION RATE WERE ATTEMPTED AND THE PATIENT INDICATED THEY FELT HEATING. THE DECISION WAS MADE TO DISCONTINUE THE SCAN. THE PATIENT INDICATED THAT THE BURNING SENSATION OCCURRED AT THE SIDES OF THE CHEST WHERE THE ENDS OF THE BARS ARE LOCATED, AND THAT THE HEATING OCCURRED ONLY WHEN THE SCANNER WAS ACQUIRING AN IMAGE. THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT FOLLOWING THE MRI. THE PATIENT HAS NOT RETURNED FOR A CARDIAC MRI DUE TO HEATING OF THE IMPLANT. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Burning Sensation

  MAUDE report 10999101 ↗