Thoracic Drain TC-xxxxxRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00803622105975), received between Feb 28, 2019 and Aug 31, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  LIVANOVA HAS RECEIVED A REPORT THAT THE CATHETER THORACIC 32FR X 20IN STRAIGHT FLARED END (CATALOGUE NUMBER TC-10132, LOT 2009000080) CONTAINED A THORACIC CATHETER FRENCH 28FR INSTEAD OF FRENCH 32FR AS PER LABELLING. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 10471113 ↗
• MalfunctionApr 3, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON MARCH 05TH, 2019, LIVANOVA USA INC HAS RECEIVED BY MAIL POST A REPORT (MW5084514) THAT A THORACIC CATHETERS, STRAIGHT, 32 FR WAS NOT MARKED WITH MANUFACTURER NAME AND SIZE, AND DRAINAGE HOLES WERE NOT COMPLETELY PUNCHED THROUGH. ACCORDING TO THE RECEIVED INFORMATION, THE DEVICE WAS REPLACED. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478756 ↗
• MalfunctionApr 3, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2019, LIVANOVA USA INC HAS RECEIVED BY MAIL POST A REPORT (MW5084514) THAT A THORACIC CATHETERS, STRAIGHT, 32 FR WAS NOT MARKED WITH MANUFACTURER NAME AND SIZE, AND DRAINAGE HOLES WERE NOT COMPLETELY PUNCHED THROUGH. ACCORDING TO THE RECEIVED INFORMATION, THE DEVICE WAS REPLACED. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8478748 ↗
• MalfunctionFeb 28, 2019Defective Component

  DEFECTIVE CHEST TUBE. SIZE 32 LIVANOVA/SORIN GROUP CHEST TUBE WAS NOT MARKED WITH COMPANY NAME OR SIZE OF TUBE AS PER USUAL. DRAINAGE HOLES IN THE CHEST TUBE WERE NOT COMPLETELY PUNCHED THROUGH. THIS LEAVES THE POSSIBILITY FOR ONE OF THE PLASTIC PIECES THAT ARE NOT COMPLETELY PUNCHED THROUGH TO BECOME LOOSE INSIDE THE PATIENT. CHEST TUBE WAS REMOVED IMMEDIATELY AFTER PLACEMENT AND REPLACED WITH A NEW, NON-DEFECTIVE CHEST TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8381710 ↗
• MalfunctionFeb 28, 2019Loose or Intermittent Connection; Therapeutic or Diagnostic Output Failure

  DEFECTIVE CHEST TUBE: SIZE 32 SORIN GROUP CHEST TUBE. CHEST TUBE NOT MARKED WITH MANUFACTURER NAME OR SIZE OF THE CHEST TUBE AS IT SHOULD BE. THE DRAINAGE HOLES IN THE CHEST TUBE WERE NOT COMPLETELY PUNCHED THROUGH. THIS LEAVES POSSIBILITY FOR ONE OF THE PLASTIC PIECES TO BECOME LOOSE INSIDE THE PATIENT. CHEST TUBE REMOVED IMMEDIATELY AFTER PLACEMENT AND REPLACED WITH A NEW, NON-DEFECTIVE CHEST TUBE. NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381701 ↗