APDL M001245070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729735694), received between Feb 14, 2022 and Feb 16, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 16, 2022Break; Break

  IT WAS NOTED THAT THE DRAIN BROKE INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE PLEURAL CAVITY. A FLEXIMA ALL PURPOSE DRAINAGE WAS SELECTED FOR USE. THE DRAIN WAS PLACE IN CHEST TUBE THORACOSTOMY POST TRIPLE BYPASS. THE PNEUMOTHORAX RESOLVED OVER THE NEXT FEW DAYS AND THE DEVICE WAS REMOVED WITHOUT ANY ISSUE. HOWEVER, THE PATIENT COMPLAINED THAT A LOT OF FORCE WAS DONE TO REMOVE THE DEVICE. A FOLLOW UP CHEST X-RAY WAS PERFORMED, AND IT WAS NOTED THAT THE TIP OF THE APDL LODGED IN THE PLEURAL CAVITY. A VIDEO-ASSISTED THORACOSCOPIC SURGERY WAS DONE TO REMOVE THE FRAGMENT. THE PATIENT'S WELL AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543778 ↗
• InjuryFeb 14, 2022Break; Break

  IT WAS NOTED THAT THE DEVICE TIP BROKE OFF AND WAS SURGICALLY RETRIEVED. A 8W APDL CATHETER DRAINAGE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE TIP BROKE OFF AND HAD TO BE SURGICALLY RETRIEVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13530072 ↗