Argyle 8888561050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521029293), received between Feb 17, 2020 and Aug 9, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 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.

• InjuryAug 9, 2024Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT DURING (B)(6) 2024, THE THORACIC CATHETER WAS KINKED AT THE POINT OF ENTRANCE, OR WAS KINKED INTRATHORACIC, AND WAS NOT FUNCTIONAL. THE PROCEDURE PERFORMED WAS A THORACIC PROCEDURE. THE PATIENT IS SAFE, BUT HOSPITALIZATION WAS PROLONGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT AT THE SECOND POSTOPERATIVE DAY, THE CHEST TUBE WAS SERIOUSLY KINKED AT THE POINT OF ENTRANCE. PER CUSTOMER, THE PATIENT WAS ALREADY HOSPITALIZED, AND THE HOSPITALIZATION WAS PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952392 ↗
• InjuryAug 9, 2024Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT DURING (B)(6) 2024, THE THORACIC CATHETER WAS KINKED AT THE POINT OF ENTRANCE, OR WAS KINKED INTRATHORACIC, AND WAS NOT FUNCTIONAL. THE PROCEDURE PERFORMED WAS A THORACIC PROCEDURE. THE PATIENT IS SAFE, BUT HOSPITALIZATION WAS PROLONGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT AT THE SECOND POSTOPERATIVE DAY, THE CHEST TUBE WAS SERIOUSLY KINKED AT THE POINT OF ENTRANCE. PER CUSTOMER, THE PATIENT WAS ALREADY HOSPITALIZED, AND THE HOSPITALIZATION WAS PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951958 ↗
• InjuryAug 9, 2024Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT DURING THE MONTH OF (B)(6) 2024, THE THORACIC CATHETER WAS KINKED AT THE POINT OF ENTRANCE, OR WAS KINKED INTRATHORACIC, AND WAS NOT FUNCTIONAL. THE PATIENT IS SAFE, BUT HOSPITALIZATION WAS PROLONGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT AT THE SECOND POSTOPERATIVE DAY, THE CHEST TUBE WAS SERIOUSLY KINKED AT THE POINT OF ENTRANCE. PER CUSTOMER, THE PATIENT WAS ALREADY HOSPITALIZED, AND THE HOSPITALIZATION WAS PROLONGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951680 ↗
• MalfunctionDec 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE BLUE HANDLE OF THE TROCAR HAS BROKEN OFF THREE TIMES IN A ROW. NO PATIENT WAS HARMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397915 ↗
• InjuryFeb 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE TIP OF THE DEVICE REMAINED IN THE CHEST OF THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TROCAR WAS REMOVED FROM THE PATIENT ENDOSCOPICALLY BEFORE THE START OF THE OPERATION AND THE PATIENT WAS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9717915 ↗