Argyle 8881450004Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521020337), received between Apr 13, 2020 and Mar 22, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING ORAL SUCTIONING, THE PLASTIC PART ON THE EDGE CAME OFF. THE PATIENT SWALLOWED THE FALLEN PART ACCIDENTALLY, AND, EVENTUALLY IT WAS RETRIEVED WITH AN ENDOSCOPE. THERE WAS NO ADDITIONAL MEDICATION OR NO FURTHER MEDICAL TREATMENT. THE PATIENT APPEARED TO BE ADVANCED AGE SINCE HE/SHE HAS NO TEETH AT ALL. THE PERIOD OF USE WAS A COUPLE OF MINUTES. THERE WAS NO INFECTION. IT DID FALL/RETAIN IN THE BODY. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960545 ↗
• MalfunctionFeb 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THEY HAVE A SAFETY ISSUE WITH A PRODUCT THAT IS USED DAILY IN THEIR GASTROINTESTINAL (GI) PROCEDURES. PER CUSTOMER, THIS IS A SALIVA EJECTOR THAT IS USED TO SUCK OUT THE SALIVA OUT OF A PATIENT¿S MOUTH WHILE THEY ARE SEDATED, MUCH LIKE A DENTIST¿S OFFICE, UNFORTUNATELY, THE SMALL PLASTIC BLUE PIECE HAS BEEN FALLING OFF VERY EASILY. THE ISSUE WAS NOTICED WHEN USED ON A PATIENT. THERE WAS NO PATIENT HARM REPORTED. THE CUSTOMER FURTHER STATED THAT THEY ARE STILL USING THE PRODUCT WITH A NEW PROTOCOL AROUND PULLING ON THE BLUE TIP FIRST TO MAKE SURE IT¿S SEATED AND NOT LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471004 ↗
• MalfunctionMar 26, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE LIQUID DOES NOT FLOW IN THE CATHETER. ADDITIONAL INFORMATION RECEIVED ON 25-JUN-2021 STATED THAT THE INCIDENT TOOK PLACE AT THE PATIENT HOME. THE ISSUE WAS THAT THE LIQUID THAT BLOCKS THE CATHETER COULD NOT BE INSERTED PROPERLY. AT THAT TIME IT WAS NOT POSSIBLE TO ESTABLISH IF IT WAS A MISTAKE OF THE USER OR IF THE CATHETER WAS FAULTY. ADDITIONAL CLARIFICATION WAS RECEIVED ON 28-JUN-2021 STATING THAT THE ISSUE DOES NOT REFER TO URINE, IT REFERS TO THE LIQUID USED TO BLOCK THE CATHETER, BECAUSE OF THIS REASON THE CATHETER COULD NOT BE CORRECTLY POSITIONED INTO THE PATIENT¿S BODY.

  Patient problems: Insufficient Information

  MAUDE report 11577543 ↗
• MalfunctionMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT WHILE PERFORMING ORAL CARE, THE CAP ON THE TIP OF THE DEVICE CAME OFF AND DROPPED INTO THE PATIENT¿S MOUTH. THE CAP WAS REMOVED FROM THE PATIENT¿S MOUTH AND THE DEVICE WAS REPLACED WITH A NEW ONE. ADDITIONAL INFORMATION STATED THAT THE CAP WAS REMOVED IMMEDIATELY USING FINGERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449487 ↗
• InjuryFeb 17, 2021Detachment of Device or Device Component

  THE CUSTOMER REPORTED DURING THE PROCEDURE THE BLUE TIP CAME OFF AND WAS LEFT INSIDE THE PATIENT'S ORAL CAVITY. THE HEALTH CARE PROVIDERS WERE ABLE TO REMOVE/ RETRIEVE IT. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11338638 ↗
• MalfunctionJun 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING INSPECTION BEFORE USE, THEY PULLED THE TIP AND THE COVER WAS REMOVED EASILY. THERE WAS NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105246 ↗
• InjuryApr 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT SEVERAL SECONDS AFTER THEY STARTED USING THE PRODUCT, THE BLUE CAP ON THE TIP HAD DROPPED INTO THE PATIENT'S MOUTH AND WAS SWALLOWED. THE CUSTOMER FURTHER ADDED THAT THE PATIENT DID NOT CHEW THE PRODUCT DURING USE AND THE VACUUM WAS SET AT 20 MMHG. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE BLUE CAP WAS REMOVED FROM THE PATIENT HOWEVER DETAILS OF HOW IT WAS REMOVED WAS NOT SHARED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 9988815 ↗
• InjuryApr 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT RIGHT AFTER THEY STARTED USING THE PRODUCT, THE BLUE CAP ON THE TIP DROPPED INTO THE PATIENT'S MOUTH. THE CAP WAS ABLE TO BE REMOVED IMMEDIATELY FROM THE PATIENT'S MOUTH AND THERE WAS NO ADDITIONAL TREATMENT NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9967168 ↗
• MalfunctionApr 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT AFTER INTRAORAL SUCTION, THE TUBE PART WAS ABLE TO BE DISCARDED INTO THE WASTE BIN, HOWEVER, THE TIP PART CAME OFF AND WAS NOT PUT INTO THE WASTE BIN. THERE WAS NO PATIENT HARM REPORTED BECAUSE THE EVENT OCCURRED AFTER USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9953720 ↗