ULTRAPRO UPPS1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031085985), received between Nov 20, 2024 and Aug 14, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THERE WERE SOME MESH FRAGMENTS INSIDE THE PACKAGE, WHICH WAS NOTICED DURING THE PROCEDURE AND THE USE WAS STOPPED. AS SIMILAR CASES HAD OCCURRED WITH BOTH OF PRODUCTS IN STOCK, SO THEIR USE WAS STOPPED. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810276 ↗
• MalfunctionAug 14, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND MESH WAS USED. WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THERE WERE SOME MESH FRAGMENTS INSIDE THE PACKAGE, WHICH WAS NOTICED DURING THE PROCEDURE AND THE USE WAS STOPPED. AS SIMILAR CASES HAD OCCURRED WITH BOTH OF PRODUCTS IN STOCK, SO THEIR USE WAS STOPPED. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810273 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT UMBILICAL HERNIA ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA AND EXCISION OF PREVIOUSLY PLACED MESH ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20732087 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT UMBILICAL HERNIA ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REPAIR OF VENTRAL HERNIA AND EXCISION OF PREVIOUSLY PLACED MESH ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNDISCLOSED INJURY. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hernia

  MAUDE report 20732086 ↗