Argyle 8888505040Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884527019977), received between Nov 2, 2021 and Nov 2, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (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.

• MalfunctionNov 2, 2021Sharp Edges; Sharp Edges

  THE CUSTOMER REPORTED THAT THEY HAD A PATIENT END UP WITH WOUNDS BEHIND THEIR MOUTH AFTER USING THIS SUCTION TIP. THE SUCTION TIP HAS HOLES ON THE SIDE NEAR THE TIP THAT ARE CUT SO THAT THE EDGES OF THE HOLES ARE SHARP.

  Patient problems: Laceration(s)

  MAUDE report 12738904 ↗
• MalfunctionNov 2, 2021Sharp Edges; Sharp Edges

  THE CUSTOMER REPORTED THAT THEY HAD A PATIENT END UP WITH WOUNDS BEHIND THEIR MOUTH AFTER USING THIS SUCTION TIP. THE SUCTION TIP HAS HOLES ON THE SIDE NEAR THE TIP THAT ARE CUT SO THAT THE EDGES OF THE HOLES ARE SHARP.

  Patient problems: Laceration(s)

  MAUDE report 12738902 ↗
• MalfunctionNov 2, 2021Sharp Edges; Sharp Edges

  THE CUSTOMER REPORTED THAT THEY HAD A PATIENT END UP WITH WOUNDS BEHIND THEIR MOUTH AFTER USING THIS SUCTION TIP. THE SUCTION TIP HAS HOLES ON THE SIDE NEAR THE TIP THAT ARE CUT SO THAT THE EDGES OF THE HOLES ARE SHARP.

  Patient problems: Laceration(s)

  MAUDE report 12738901 ↗