Argyle 888570549KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253057348), received between Jan 12, 2026 and Feb 5, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Material Puncture/Hole

  THE CUSTOMER REPORTED THAT DURING RIGHT MINIMALLY INVASIVE THORACOSCOPIC OPERATION FOR A PNEUMOTHORAX, A 28FR STRAIGHT CHEST TUBE WAS PLACED THROUGH ONE OF THE INCISIONS AT THE CONCLUSION OF THE OPERATION. ON A POSTOPERATIVE FILM, THE CUSTOMER OBSERVED A RADIO-OPAQUE STRUCTURE ALONG THE CHEST TUBE IN THE SOFT TISSUE NEAR THE INCISION. THIS CORRESPONDS TO THE RADIO-OPAQUE SIDE HOLE OF THE TUBE THAT IS CUT BY THE MANUFACTURER OF THE TUBE PRIOR TO PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS NO ADDITIONAL BREAKAGE TO CATHETER, IT WAS THE CUT OUT SIDE HOLE PIECE. ACCORDING TO THE CUSTOMER, THE PIECE WAS EVENTUALLY REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24274853 ↗
• MalfunctionJan 12, 2026

  DURING RIGHT MINIMALLY INVASIVE THORACOSCOPIC OPERATION FOR A PNEUMOTHORAX, AT THE CONCLUSION OF THE OPERATION A CHEST TUBE WAS PLACED THROUGH ONE OF THE INCISIONS - 28FR STRAIGHT CHEST TUBE. ON A POSTOPERATIVE FILM, I NOTICED A RADIO-OPAQUE STRUCTURE ALONG THE CHEST TUBE IN THE SOFT TISSUE NEAR THE INCISION. THIS CORRESPONDED TO THE RADIO-OPAQUE SIDE HOLE OF THE TUBE THAT IS CUT BY THE MANUFACTURER OF THE TUBE PRIOR TO PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031483 ↗