Argyle 8888301614Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884527019653), received between Sep 26, 2019 and Feb 28, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE SUCTION TUBING WILL NOT REMAIN INTACT TO A SCOPE OR MEDICAL DEVICE CAUSING A POTENTIAL EXPOSURE TO BLOOD AND BODY FLUIDS, AND A PATIENT SAFETY HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18797890 ↗
• MalfunctionJan 23, 2024Decrease in Suction; Detachment of Device or Device Component; Decrease in Suction; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE SUCTION TUBING DOES NOT PROVIDE A TIGHT SEAL WHEN ATTACHED TO THE SCOPES. THE TUBING FALLS OFF REGULARLY AND THE SUCTION STRENGTH IS SIGNIFICANTLY IMPACTED DUE TO A LOOSE SEAL. THEY CAN NOT CLEAR THE GI TRACT OF LIQUID QUICKLY, WHICH CAN BE LIFE THREATENING IF THERE IS A SIGNIFICANT BLEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18562819 ↗
• MalfunctionJan 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE SUCTION TUBING WILL NOT REMAIN INTACT TO A SCOPE OR MEDICAL DEVICE, CAUSING A POTENTIAL EXPOSURE TO BLOOD AND BODY FLUIDS AND A PATIENT SAFETY HAZARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18534145 ↗
• MalfunctionMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE JOINT CONNECTOR ON THE SUCTION TUBE IS DISENGAGED. THE PRODUCT WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945316 ↗
• MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT SINGLE USE SUCTION TUBING FELL APART DURING SURGICAL PROCEDURE. THE BLUE RUBBER CONNECTOR END OF THE SUCTION TUBING CAME APART FROM THE CLEAR TUBE DURING THE PROCEDURE AT A VERY CRITICAL TIME DURING WHEN SUCTION WAS NEEDED URGENTLY BECAUSE OF BLEEDING AT THE SURGICAL SITE. THE TUBING WAS IMMEDIATELY REMOVED FROM THE SURGICAL SITE AND THE ANAESTHETIC TECHNICIAN OPENED ANOTHER TUBING STRAIGHT AWAY. THE CUSTOMER HAD SAFETY CONCERNS AS THE EVENT HAPPENED AT A CRITICAL TIME DURING THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED DURING THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13607174 ↗
• MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE MALE CONNECTOR ISN'T GLUED/ADHERING, SO IT COMES OFF IN HAND. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE ISSUE OCCURRED DURING PATIENT USE. THE CONNECTOR WAS NOT LOOSE IN THE STERILE PACKAGING, PRIOR TO OPENING. THE EXACT DETAILS OF THE DETACHMENT ARE NOT KNOWN BUT THE CONNECTOR CAME OFF EITHER WHEN DISCONNECTING IT, MOVING THE TUBING E.G., TO MOVE IT UNDER A PILLOW, OR WHEN TRYING TO USE SUCTION DURING SURGERY. THERE WAS NO PATIENT HARM REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13605594 ↗
• MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE MALE CONNECTOR ISN'T GLUED/ADHERING SO IT COMES OFF IN HAND. THERE WAS NO PATIENT HARM. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, THE ISSUE OCCURRED DURING PATIENT USE. THE CONNECTOR WAS NOT LOOSE IN THE STERILE PACKAGING PRIOR TO OPENING. THE EXACT DETAILS OF THE DETACHMENT ARE NOT KNOWN BUT THE CONNECTOR CAME OFF EITHER WHEN DISCONNECTING IT, MOVING THE TUBING E.G., TO MOVE IT UNDER A PILLOW, OR WHEN TRYING TO USE SUCTION DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601711 ↗
• MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE MALE CONNECTOR ISN'T GLUED/ADHERING SO IT COMES OFF IN HAND. THERE WAS NO PATIENT HARM. PER ADDITIONAL INFORMATION PROVIDED ON FEBRUARY 16, 2022, THE ISSUE OCCURRED DURING PATIENT USE. THE CONNECTOR WAS NOT LOOSE IN THE STERILE PACKAGING, PRIOR TO OPENING. THE EXACT DETAILS OF THE DETACHMENT ARE NOT KNOWN BUT THE CONNECTOR CAME OFF EITHER WHEN DISCONNECTING IT, MOVING THE TUBING E.G., TO MOVE IT UNDER A PILLOW, OR WHEN TRYING TO USE SUCTION DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601672 ↗
• MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE MALE CONNECTOR ISN'T GLUED/ADHERING SO IT COMES OFF IN HAND. THERE WAS NO PATIENT HARM. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, THE ISSUE OCCURRED DURING PATIENT USE. THE CONNECTOR WAS NOT LOOSE IN THE STERILE PACKAGING, PRIOR TO OPENING. THE EXACT DETAILS OF THE DETACHMENT ARE NOT KNOWN BUT THE CONNECTOR CAME OFF EITHER WHEN DISCONNECTING IT, MOVING THE TUBING E.G., TO MOVE IT UNDER A PILLOW, OR WHEN TRYING TO USE SUCTION DURING SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13601592 ↗
• MalfunctionOct 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE BLUE CONNECTOR IS NOT ATTACHED AND THE TRANSPARENT CONNECTOR IS MISSING IN THE PACKAGE. THE ISSUE WAS FOUND BEFORE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722083 ↗
• MalfunctionJan 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE CONNECTOR IS NOT ATTACHED TO THE TUBING. ADDITIONAL INFORMATION RECEIVED ON 09-JAN-2020 STATING THAT THERE WERE NO OTHER PHYSICAL ISSUE TO THE TUBING OR THE PACKAGING NOTED. ADDITIONAL INFORMATION RECEIVED ON 13-JAN-2020 STATED THAT BOTH CONNECTORS WERE PRESENT WHICH ONE DETACHED. THE ISSUE WAS FOUND WHEN SETTING UP FOR THE CASE AND NOT IN THE MIDDLE OF THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9591749 ↗
• MalfunctionJan 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED BOTH CONNECTORS WERE PRESENT IN THE PACKAGE BUT ONE WAS DETACHED FROM THE TUBING. THIS WAS NOTICED WHEN SETTING UP FOR THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586915 ↗
• MalfunctionJan 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED BOTH CONNECTORS WERE PRESENT IN THE PACKAGE BUT ONE WAS DETACHED FROM THE TUBING. THIS WAS NOTICED WHEN SETTING UP FOR THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586727 ↗
• MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THEY FOUND THE ARGYLE SUCTION CONNECTOR WAS DETACHED FROM THE TUBING WHEN THEY OPENED THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 9124556 ↗