Argyle 8888571059Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521060937), received between Jun 30, 2023 and Jul 17, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionJul 17, 2024Break; Break

  THE CUSTOMER REPORTED THAT THE PERICARDIAL CHEST TUBE NOTED TO BE CRACKED/DISCONNECTED AFTER PATIENT REPORTED HEARING SLURPING" SOUNDS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761868 ↗
• MalfunctionOct 18, 2023Defective Component; Defective Component

  THE CUSTOMER REPORTED THE PATIENT SIDE OF THE CHEST TUBE HAD A PLASTIC PIECE LODGED INSIDE THE TUBE THAT SHOULD HAVE BEEN REMOVED DURING MANUFACTURING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956754 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER CUSTOMER, THE STAFF SURGEON STATED THAT THE STIFF CHEST TUBE COMPRESSED THE IVC AND MIMICKED CARDIAC TAMPONADE IN A PATIENT. THE HEMODYNAMIC INSTABILITY WAS RESOLVED AFTER THE CHEST TUBE WAS REMOVED. PER STAFF SURGEON, THERE WAS NO MALFUNCTION PER SE OF THE CHEST TUBE. THE STAFF SURGEON EXPLAINED THAT THE ISSUE WAS THAT THE TUBE IN QUESTION WAS MUCH STIFFER THAN THEIR PRIOR PRODUCTS.

  Patient problems: Cardiac Tamponade

  MAUDE report 17239046 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER CUSTOMER, THE STAFF SURGEON STATED THAT THE CHEST TUBE CAUSED TAMPONADE AND IT¿S NOT SAFE FOR CARDIAC PATIENTS. NO MEDICAL INTERVENTION WAS REQUIRED, AND NO INTUBATION WAS NECESSARY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON AND STATED THAT THE ORIGINAL INTENDED PROCEDURE FOR THIS PATIENT WAS CORONARY ANGIOGRAPHY. THERE WAS NO MALFUNCTION PER SE OF THE CHEST TUBE. THE STAFF SURGEON FURTHER EXPLAINED THAT THE ISSUE WAS THAT THE TUBE IN QUESTION WAS MUCH STIFFER THAN THEIR PRIOR PRODUCTS. THE EVENT RESULTED IN COMPRESSION OF A BYPASS GRAFT, AND IN THIS EVENT, IT WAS NOT TAMPONADE. THE CHEST TUBE WAS REMOVED AS A RESULT AND THE PATIENT WAS DISCHARGED HOME. THE CUSTOMER FURTHER STATED ON (B)(6)2023, THAT THE INCISION WAS MADE WITH A BLADE AND A TRACK WAS CREATED WITH A KELLY FORCEPS AND THEN THE CHEST TUBE WAS INSERTED IN STANDARD FASHION. THE CUSTOMER IS NOW USING TELEFLEX TUBES.

  Patient problems: Cardiac Tamponade

  MAUDE report 17238440 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER CUSTOMER, THE STAFF SURGEON STATED THAT THE CHEST TUBE CAUSED TAMPONADE AND IT¿S NOT SAFE FOR CARDIAC PATIENTS. NO MEDICAL INTERVENTION WAS REQUIRED, AND NO INTUBATION WAS NECESSARY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON AND STATED THAT THE ORIGINAL INTENDED PROCEDURE FOR THIS PATIENT WAS CORONARY BYPASS SURGERY. THERE WAS NO MALFUNCTION PER SE OF THE CHEST TUBE. THE SURGEON FURTHER EXPLAINED THAT THE ISSUE WAS THAT THE TUBE IN QUESTION WAS MUCH STIFFER THAN THEIR PRIOR PRODUCTS. AS SUCH, THEY ARE PRONE TO CAUSE COMPRESSION OF ADJACENT STRUCTURES (THE DISTAL RCA AND A RITA TO RCA GRAFT). THE EVENT RESULTED IN MORBIDITY TO THE PATIENT INVOLVED. THE CHEST TUBE WAS REMOVED AS A RESULT. THE SURGEON FURTHER STATED THAT THE PATIENT EXPIRED. AT THIS TIME THE CAUSE OF DEATH IS UNKNOWN, AND IT WAS UNKNOWN IF THERE WAS ANY CORRELATION BETWEEN THE REPORTED INCIDENT AND THE PATIENT¿S DEATH. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2023, AND STATED THAT THE CAUSE OF DEATH IS UNKNOWN, BUT LIKELY PULMONARY EMBOLUS. THE CUSTOMER FURTHER STATED ON (B)(6) 2023, THAT THE INCISION WAS MADE WITH A BLADE AND A TRACK WAS CREATED WITH A KELLY FORCEPS AND THEN THE

  Patient problems: Cardiac Tamponade

  MAUDE report 17237480 ↗