Argyle 8888514604Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884521149161), received between Aug 6, 2020 and Sep 22, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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.

• MalfunctionSep 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTS: THERE IS A SMALL HOLE/CRACK IN THE PENROSE TUBING LOCATED WHERE THE TUBE WAS BENT INSIDE THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804132 ↗
• MalfunctionSep 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTS: THERE IS A SMALL HOLE/CRACK IN THE PENROSE TUBING LOCATED WHERE THE TUBE WAS BENT INSIDE THE PACKAGING. THE DRAIN APPEARED INTACT HOWEVER THE HOLE/CRACK WAS NOTICED ONCE TENSION WAS APPLIED TO THE DRAIN. ONCE NOTICED, A NEW DRAIN WAS REQUESTED WHICH WAS INSPECTED PRIOR TO GIVING TO THE SURGEON. A FEW OTHER PACKAGES ALSO HAD THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17802742 ↗
• MalfunctionAug 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE PRODUCT WAS FALLING APART WHEN TRYING TO USE THEM. THE ISSUE WAS NOTICED ALMOST IMMEDIATELY UPON OPENING THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10373368 ↗