PICO 66800952Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05000223477097), received between Oct 2, 2020 and Mar 23, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THA PERFORMED ON (B)(6) 2022, THE PATIENT FELL AND THE WOUND BECAME DEHISCED. A PICO 7 WAS APPLIED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED ON (B)(6)2022. WHEN THE DRESSING WAS SATURATED THE HOMECARE NURSE APPLIED ALLEVYN ADHESIVE AND COVERS THE DRESSING WITH PICO 7. ON (B)(6) 2022 PATIENT RETURNS TO HOSPITAL AND THERE IS A SUSPICION OF MILD INFECTION. ON (B)(6)2022, PATIENT REOPERATED DUE TO DEEP INFECTION. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 13870466 ↗
• MalfunctionMar 14, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING TREATMENT WITH PICO PUMP. WHEN BATTERIES WERE PUT IN PUMP, ALL LIGHTS CONTINUED TO ILLUMINATE AND DEVICE WOULD NOT WORK. BACK UP WAS AVAILABLE, NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478982 ↗
• MalfunctionJan 13, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT ALL LIGHTS ILLUMINATED ON PICO. THE DEVICE WAS BEING USED ON A C-SECTION. A NEW PRODUCT WAS USED WITH NO DELAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167444 ↗
• MalfunctionJan 13, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT ALL LIGHTS ILLUMINATED ON PICO. THE DEVICE WAS BEING USED ON A C-SECTION. A NEW PRODUCT WAS USED WITH NO DELAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167434 ↗
• MalfunctionJan 13, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT ALL LIGHTS ILLUMINATED ON PICO. THE DEVICE WAS BEING USED ON A C-SECTION. A NEW PRODUCT WAS USED WITH NO DELAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167431 ↗
• MalfunctionOct 2, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT WHEN USING A PICO 7 AFTER A C-SECTION, THE DEVICE WOULDN¿T WORK. ALL 3 LIGHTS FLASHED, THE NURSE CHANGED THE BATTERY AND IT STILL DIDN¿T WORK. ANOTHER SET WAS USED. NO PATIENT HARM REPORTED, AND THERE WAS NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10622044 ↗