PICO 66800954Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05000223477134), received between Nov 19, 2020 and May 25, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (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. How this data works · Data updated Oct 13, 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 25, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING NPWT, THE PICO SINGLE USE NPWT 15 X 15CM WAS NOT LONGER FUNCTIONAL. THE BATTERY WAS CHANGED BUT THE ISSUE PERSIST. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881070 ↗
• MalfunctionDec 3, 2020Pumping Stopped; Pressure Problem; Pumping Stopped; Pressure Problem

  IT WAS REPORTED THAT DURING TREATMENT PICO 7 15X15 PUMP WAS GIVING ALL LIGHTS PROMPT AND NOT WORKING. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938099 ↗
• MalfunctionNov 19, 2020Pumping Stopped; Defective Device; Pumping Stopped; Defective Device

  IT WAS REPORTED THAT THE PUMP DID NOT WORK WHEN IT WAS TAKEN OUT OF THE BOX AND ALL THE LIGHTS WERE FLASHING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10872269 ↗