Argyle 8888561068Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521029309), received between Jan 31, 2022 and Aug 9, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 4 most recent of 4 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 THE END OF (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 19955246 ↗
• InjuryAug 9, 2024Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT DURING THE END OF (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 19955042 ↗
• MalfunctionFeb 9, 2022Component Missing; Component Missing

  THE CUSTOMER REPORTED 1 GREEN TROCAR CATHETER HAD ONLY A NEEDLE IN THE PACKAGE AND NO DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497705 ↗
• InjuryJan 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS: A PIECE OF PVC (FROM THE (B)(6)) WAS STILL IN THE CATHETER AND GOT LOST IN THE PATIENTS' BODY. FORTUNATELY, THE PART THAT DETACHED WAS THE PIECE WITH THE X-RAY LINE ON IT SO THEY WERE ABLE TO DETECT AND REMOVE IT AFTERWARDS. THE PIECE WAS FOUND CLOSE TO THE PATIENTS' RIBS. THERE WAS NO IMMEDIATE PATIENT HARM, HOWEVER, THERE WERE SEVERAL EXTRA-STEPS NECESSARY. THE CATHETER HAD TO BE CHANGED AND REPLACED AND THE PATIENT WAS UNDER ANESTHESIA FOR AN EXTENDED TIME PERIOD WHILE REMOVING THIS PART. THE PATIENT AS WELL AS THE LEGAL DEPARTMENT AT THE HOSPITAL WERE INFORMED ABOUT THIS CASE. THEY TRIED TO DOCUMENT THIS INCIDENT VIA PHOTOS. THE SALES REPRESENTATIVE HAS AN APPOINTMENT WITH THE CHIEF SURGEON NEXT WEEK TO DISCUSS FURTHER STEPS AT WHICH TIME, PHOTOGRAPHS ARE EXPECTED TO BE PROVIDED TO THE SALES REPRESENTATIVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13403775 ↗