PREVENA™ PEEL & PLACE™ PRE1101USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00849554004627), received between Jun 9, 2025 and May 27, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem: Low Impedance” (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.

• MalfunctionMay 27, 2026

  MULTIPLE CAREGIVERS REPORTED THAT THE PREVENA INCISION MANAGEMENT SYSTEM FREQUENTLY HAD QUALITY ISSUES. REPORTED ISSUES WERE BLISTERING PATIENT SKIN ON REMOVAL, DIFFICULT TO USE, NOT SEALING PROPERLY, AND HAVING TO BE CHANGED MORE FREQUENTLY THAN THE PREVIOUS BRAND USED BY THE HOSPITAL. ALL SURGEONS INDEPENDENTLY STOPPED USING THE DRESSINGS. THEY HAVE BEEN REPLACED WITH ANOTHER BRAND THAT IS OF A BETTER QUALITY.

  Patient problems: Blister

  MAUDE report 25299744 ↗
• MalfunctionDec 16, 2025Battery Problem: Low Impedance

  DEFECTIVE BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815559 ↗
• MalfunctionJun 9, 2025Failure to Seal

  REPORTED BY THE OPERATING ROOM THAT THE DRESSING WOULD NOT SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166144 ↗