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PICO 66022031Recalls & reported problems

Smith & Nephew Medical Limited · PICO 7Y KIT MULTISITE LARGE 20X25CM · Class 2

All models of PICO (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223494391), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pumping Stopped” (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 16, 2026.

Most reported problems

Device problems

  • Pumping Stopped1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 7, 2021Pumping Stopped; Pumping Stopped

    IT WAS REPORTED THAT WHEN OPENED, THE PICO 7Y IMMEDIATELY HAD THE 3 LIGHTS GO ON SIMULTANEOUSLY AND THE PUMP WOULD NOT WORK. THE ISSUE WAS SOLVED WITH A BACKUP DEVICE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11132049 ↗

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Sources and updates

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