Argyle 8888570549Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521050846), received between Feb 6, 2020 and Sep 11, 2025 — classified as 1 death, 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE CHEST TUBE BROKE DURING USE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS NO INJURY REPORTED AND IT WAS UNKNOWN IF THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027312 ↗
• MalfunctionAug 27, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED AN ARGYLE CHEST TUBE FRACTURED INSIDE A PATIENT, REMOVED IN THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22905848 ↗
• MalfunctionAug 27, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED AN ARGYLE CHEST TUBE FRACTURED INSIDE A PATIENT, REMOVED IN THE SAME PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22905695 ↗
• InjuryAug 27, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT ARGYLE CHEST TUBE FRACTURING INSIDE PATIENT. ADDITIONAL INFORMATION RECEIVED STATING THE PATIENT HAD TO HAVE AN ADDITIONAL PROCEDURE TO HAVE THE REMAINING PART OF THE TUBE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22905507 ↗
• InjuryAug 27, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED AN ARGYLE CHEST TUBE FRACTURED INSIDE A PATIENT AND THEY HAD TO HAVE AN ADDITIONAL PROCEDURE TO HAVE THE REMAINING PART OF THE TUBE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22905194 ↗
• DeathJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THERE WAS A PARTIAL DISLODGE OF CHEST TUBE WITH EXPOSED EYELET AND SUTURE FELL OFF. NO UNUSUAL CIRCUMSTANCES NOTED. THE CLINICAL STAFF NOTICED WORSENING AIR LEAK AND INFORMED THE TEAM. THE NURSE PRACTITIONER (NP) AND SURGEON CAME TO ASSESS AND DISCOVERED PARTIAL DISLODGE. THE CHEST TUBE WAS REMOVED. THE PATIENT DETERIORATED OVER THE NEXT FEW DAYS, TRANSFERRED TO ICU AND INTUBATED. THIS WAS MOST LIKELY DUE TO UNDERLYING CLINICAL FACTORS, BUT THE CHEST TUBE DISLODGES LIKELY CONTRIBUTED TO DETERIORATION AS WELL (<50%). IT IS VERY UNUSUAL TO HAVE A PARTIAL DISLODGE WITH EYELET EXPOSURE, SO THEY HAD TO PROVIDE ADDITIONAL STAFF EDUCATION AND UPDATE THEIR POLICY TO INCLUDE THIS SITUATION. PER CUSTOMER, THE CHEST TUBE WAS IN FOR 5 DAYS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS NO DETACHMENT, SPLITS OR BREAKS. DUE TO THE TUBE BEING VERY RIGID AND DIFFICULT TO SUTURE TO THE CHEST WALL, AN EYELET THAT SHOULD HAVE BEEN BELOW THE DERMIS IN THE CHEST WALL TO FACILITATE DRAINAGE WAS EXPOSED. THE PATIENT HAD MULTIPLE COMORBIDITIES; DETERIORATION NOT LIKELY DUE TO THE PARTIAL DISLODGE. PATIENT DETERIORATION WAS ATTRIBUTED TO PATIENT

  Patient problems: Insufficient Information

  MAUDE report 21160650 ↗
• MalfunctionApr 17, 2024Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT AT LEAST TWO BOXES ARE FAULTY - THEY ARE STIFF AND EASILY KINKED AND THIS LEAD TO EARLY BLOCK AFTER SURGERY AND THE TUBE IS NOT FLEXIBLE. THE CUSTOMER STATED THAT THERE WAS NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19125104 ↗
• InjuryFeb 5, 2024Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT AT THE FIRST POSTOPERATIVE DAY, THE TUBE HAS COLLAPSED, RENDERING IT INEFFECTIVE AND POSING A LIFE-THREATENING SITUATION FOR THE PATIENT. THE CHEST TUBE WAS SERIOUSLY KINKED INTRATHORACIC AND NON FUNCTIONAL (PHOTO). DURING THE THORACIC PROCEDURE, THEY DEVELOPED SERIOUS SUBCUTANEOUS EMPHYSEMA AT EARLY POSTOPERATIVE TIME. THE PATIENT HAD SERIOUS COMPLICATIONS AND PROLONGED HOSPITALIZATION.

  Patient problems: Pulmonary Emphysema

  MAUDE report 18646770 ↗
• InjuryFeb 5, 2024Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT DURING THE THORACIC SURGERY INCIDENT, A CHEST TUBE WAS INSERTED. UNFORTUNATELY, THE TUBE COLLAPSED, RENDERING IT INEFFECTIVE AND POSED A LIFE-THREATENING SITUATION FOR THE PATIENT. IN MORE DETAIL, THE CUSTOMER REPORTED THAT IN THE LAST TWO MONTHS AND FROM THEIR PATIENT'S OUTCOME, THEY OBSERVED A POSSIBLE CHEST DRAINAGE SYSTEM DISORDER. DURING THE THORACIC PROCEDURE, THEY DEVELOPED SERIOUS SUBCUTANEOUS EMPHYSEMA AT EARLY POSTOPERATIVE TIME. THERE WAS A NORMAL DRAINAGE SYSTEM MOVEMENT WITHOUT AN AIR LEAK DURING RESPIRATION AND EMPHYSEMA WAS PRESENT. WHEN THEY PUT SUCTION AT THE SYSTEM, A SERIOUS AIR LEAK WAS PRESENT. THE PATIENT HAD SERIOUS COMPLICATIONS AND PROLONGED HOSPITALIZATION.

  Patient problems: Pulmonary Emphysema

  MAUDE report 18646767 ↗
• InjuryFeb 5, 2024Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT AT THE SECOND POSTOPERATIVE DAY, THE TUBE HAS COLLAPSED, RENDERING IT INEFFECTIVE AND POSING A LIFE-THREATENING SITUATION FOR THE PATIENT. THE CHEST TUBE WAS SERIOUSLY KINKED AT THE POINT OF ENTRANCE (PHOTO). DURING THE THORACIC PROCEDURE, THEY DEVELOPED SERIOUS SUBCUTANEOUS EMPHYSEMA AT EARLY POSTOPERATIVE TIME. THE PATIENT HAD SERIOUS COMPLICATIONS AND PROLONGED HOSPITALIZATION.

  Patient problems: Pulmonary Emphysema

  MAUDE report 18646764 ↗
• MalfunctionMay 17, 2021Component Missing; Component Missing

  THE CUSTOMER REPORTED THAT THEY OPENED A NEW THORACIC CATHETER 28FR AND NOTHING WAS IN THE PACKAGE. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER ON 6-MAY-2021 STATED THAT THE DEVICE WAS NOT BEING USED IN AN EMERGENCY SITUATION. THERE WAS NO SIGNIFICANT DELAY TO NOTE. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. A NEW THORACIC CATHETER PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837663 ↗
• MalfunctionFeb 5, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE HOLES OF THE DRAINAGE HOSE ARE NOT CORRECTLY PUNCHED OUT AND ARE STILL AT THE HOSE. THE PIECE OF PLASTIC SEEMS TO HAVE COME FROM ONE OF THE HOLES ON THE CATHETER. THE ISSUE WAS NOTICED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11285412 ↗
• MalfunctionFeb 6, 2020Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED THAT AFTER SURGERY THE SURGEON NEEDED TO PLACE A CHEST DRAIN. THE SURGEON REALIZED BEFORE PLACING THE CHEST DRAIN THAT THE DRAIN DID NOT HAVE ANY HOLES AT THE END OF DRAIN TUBING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678679 ↗