SurgiSleeve WPXSM24Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884521203799), received between Oct 30, 2018 and Oct 8, 2022 — 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZED THE HANDLE. IT WAS ALSO STATED THAT THE SLEEVE PROTECTOR WAS BROKEN. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15568541 ↗
• MalfunctionNov 23, 2021Break; Break

  ACCORDING TO THE REPORTER DURING VIDEO ASSISTED THORACOSCOPIC SURGERY, THERE WAS A HOLE ON THE DEVICE. TO FIX THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12860491 ↗
• MalfunctionOct 30, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACIC PROCEDURE, WHEN THEY PLACED THE WOUND PROTECTOR INTO THE CHEST WALL, THE MEMBRANE WAS BROKEN. THEY USED THE OTHER NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8019926 ↗