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PICO 66800953Recalls & reported problems

Smith & Nephew Medical Limited · PICO Single Use Negative Pressure Wound Therapy System 10cm X 40cm 4in. X 16in. · Class 2

All models of PICO (13)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05000223477110), received between Dec 23, 2020 and Dec 23, 2020 — classified as 1 injury.

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 18, 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.

  • InjuryDec 23, 2020Pumping Stopped; Pumping Stopped

    IT WAS REPORTED THAT, DURING TREATMENT WITH PICO7 10X40 DRESSING, ALL ITS INDICATOR LIGHTS WERE ON AND THE DEVICE DID NOT PERFORM VACUUM. THERE WAS A CHANGE IN PROCEDURE DUE TO THIS ISSUE AND ANOTHER UNSPECIFIED DRESSING WAS USED. NO DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11066695 ↗

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Sources and updates

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