Pico 14 66022043Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05000223495398), received between Nov 4, 2020 and Jan 21, 2021 — classified as 4 malfunctions.

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

• MalfunctionJan 21, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING SET UP THE PICO DEVICE HAD ALL LIGHTS ILLUMINATED AND NEW PICO HAD TO BE OPENED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207903 ↗
• MalfunctionJan 20, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING SET UP THE PICO DEVICE HAD ALL LIGHTS ILLUMINATED AND NEW PICO HAD TO BE OPENED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205202 ↗
• MalfunctionNov 4, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT IN A PICO 14 10X30, ALL LIGHTS ILLUMINATED ON PUMP. NO HARM OR INJURY REPORTED ON PATIENT. A SMITH AND NEPHEW BACK UP DEVICE WAS USED INSTEAD. IT IS UNKNOWN IF THERE WAS ANY DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10788019 ↗
• MalfunctionNov 4, 2020Failure to Pump; Pumping Stopped; Failure to Pump; Pumping Stopped

  IT WAS REPORTED THAT IN A PICO 14 10X30, ALL LIGHTS ILLUMINATED ON PUMP. NO HARM OR INJURY REPORTED ON PATIENT. A SMITH AND NEPHEW BACK UP DEVICE WAS USED INSTEAD. IT IS UNKNOWN IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10788013 ↗