SurgiSleeve WPXLGR1117Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521521728), received between Nov 22, 2017 and Mar 30, 2022 — classified as 3 malfunctions.

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

• MalfunctionMar 30, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, WHILE USING ON THE SKIN WHEN PERFORMING OPEN SURGERY, THE SEAL OF THE DEVICE WAS DAMAGED. SURGEON REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13951661 ↗
• MalfunctionDec 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AS THE DEVICE WAS TRIED TO BE ROLLED DURING A PROXIMAL PANCREATICODUODENECTOMY, PLASTIC LIKE PIECES FELL TO THE OPERATIVE FIELD. THEY STOPPED USING THE DEVICE AND A NEW PRODUCT WAS USED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8141594 ↗
• MalfunctionNov 22, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A PROXIMAL PANCREATICODUODENECTOMY PROCEDURE, THE USER SET THE PRODUCT TO WOUND AND ROLLING, THEN THE SLEEVE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7054923 ↗