PICO 66022005Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05000223492205), received between Oct 28, 2020 and Feb 17, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 17, 2021Pumping Stopped

  IT WAS REPORTED THAT THE PICO PUMP DOES NOT WORK. IT HAS ALL ALARM LIGHTS ON AND THE GREEN OK IS ALSO ON CONSTANTLY. THIS WAS BRAND NEW PUMP AND NOT A USED PUMP. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11336297 ↗
• MalfunctionNov 18, 2020Failure to Pump; Pressure Problem; Failure to Pump; Pressure Problem

  IT WAS REPORTED THAT BEFORE TREATMENT, WHEN THE HCP OPENED THE KIT AND ASSEMBLED THE PUMP ALL THE LIGHT INDICATORS TURNED ON AND THE PUMP WAS UNABLE TO DELIVER NEGATIVE PRESSURE. A BACKUP DEVICE WAS AVAILABLE AND SOLVED THE ISSUE. 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 Known Impact Or Consequence To Patient

  MAUDE report 10859617 ↗
• MalfunctionOct 28, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT ALL THE LIGHTS CAME ON AND THE DEVICE WILL NOT TURN OFF AND THERE IS NO SUCTION. NO PATIENT WAS INVOLVED AND A BACKUP WAS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10749856 ↗