Argyle 8888509703Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884527019731), received between Jan 28, 2025 and Feb 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Break

  THE CUSTOMER REPORTED THE TIP APPEARED TO BE CHIPPED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24423016 ↗
• MalfunctionAug 7, 2025Break; Break

  THE CUSTOMER REPORTED A HEAD NURSE IN THE OPERATING ROOM STATED THE PART THAT HOLDS THE EXTENDED OUTER SHEATH BROKE EASILY. PERIOD OF USE: SOON AFTER THE OPERATION. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736784 ↗
• MalfunctionJan 28, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE EDGE OF THE SUCTION TUBE WAS MISSING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT AT THE CUSTOMER END, THEY OPENED THE INDIVIDUAL PACKAGE FOR USE. DURING USE, THEY NOTICED THAT A PART WAS MISSING. THEY CHECKED THE PACKAGE FOR ANY MISSING PART LEFT, HOWEVER, THERE WAS NO PART INSIDE THE PACKAGE. HENCE, IT IS CONSIDERED THE PRODUCT WAS INITIALLY MISSING A PART AND PACKED AS INCOMPLETE. THE ISSUE WAS NOTICED DURING OPERATION; THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21258003 ↗