ULTRAPRO ADVANCED UPA37615Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031237025), received between Oct 6, 2021 and Sep 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• MalfunctionSep 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND MESH WAS USED. UPON OPENING THE PACKAGE, THE CIRCULATING NURSE NOTICED THE PACKAGE HAD A HOLE IN IT. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. PRODUCT WAS NOT USED ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812396 ↗
• MalfunctionSep 25, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND MESH WAS USED. UPON OPENING THE PACKAGE, THE CIRCULATING NURSE NOTICED THE PACKAGE HAD A HOLE IN IT. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. PRODUCT WAS NOT USED ON THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812358 ↗
• MalfunctionOct 6, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIA REPAIR ON (B)(6) 2021 AND THE MESH WAS USED. IT WAS REPORTED THAT THERE WAS A PIN-SIZED HOLE IN THE PACKAGING OF THE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12585039 ↗