PREVENA™ PEEL & PLACE™ PRE1001USRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849554000117), received between Feb 6, 2018 and Jan 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026

  DURING A CORONARY ARTERY BYPASS GRAFT (ON PUMP), THE PREVENA SPONGE WAS PLACED ON THE PATIENT, AND THE DEVICE FAILED TO MAINTAIN SUCTION. A SWITCH WAS MADE TO ANOTHER LARGE WOUND VAC MACHINE AND SPONGE SUCTION BECAME STEADY. NO HARM TO PATIENT, PREVENA DEVICE WAS GIVEN TO COORDINATOR AFTER THE CASE TO WORK WITH VENDOR REGARDING SUCTION CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214611 ↗
• MalfunctionSep 17, 2024

  C-SECTION: INCISION MANAGEMENT SYSTEM WOULDN'T SHUT OFF ONCE SECURED TO PATIENT. BATTERY HAD TO BE REMOVED IN ORDER TO GET PUMP TO SHUT OFF. FOAM DRESSING WAS SECURE AROUND ENTIRE PERIMETER - BUT UNABLE TO USE ON PATIENT DUE TO NON-FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236110 ↗
• MalfunctionFeb 4, 2020Defective Device

  ADULT MALE SCHEDULED FOR ELECTIVE STATE 2 BRACHIOBASILIC FISTULA. AT END OF CASE RN CIRCULATOR WENT TO FIRE UP WOUND VAC AND PREVENA BOX WOULD NOT SEAL DOWN SPONGE. RN TRIED TO TROUBLE SHOOT BOX AND TURN OFF/ON; SPONGE WOULD NOT SEAL DOWN. PER SURGEON THE RN CIRCULATOR OPENED NEW PREVNA BOX FROM ANOTHER KIT WITH SUCCESS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9664832 ↗
• MalfunctionFeb 6, 2018Battery Problem

  THE BATTERY PACK ON THE KCI MACHINE FAILED SO WE OPENED A SECOND DEVICE AND THAT ONE WORKED. THE FIRST PACKAGE WAS SENT BACK FOR CREDIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7243546 ↗