PECTUS SYSTEM 01-3711Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841036011017), received between Apr 18, 2019 and Sep 7, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Edema

  MAUDE report 10499550 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Edema; Swelling

  MAUDE report 10499547 ↗
• InjurySep 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Edema

  MAUDE report 10499543 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Edema

  MAUDE report 10484844 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Pain; Swelling

  MAUDE report 10462575 ↗
• InjuryMay 8, 2019Migration; Migration

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Information

  MAUDE report 8593425 ↗
• InjuryApr 18, 2019Migration; Migration

  THE SURGEON SENT A RESPONSE STATING THAT THE BLEEDING THE PATIENT EXPERIENCED WAS RELATED TO PATIENT CONDITION.

  Patient problems: Erosion; Extraskeletal ossification; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 8527978 ↗