Pico 14 66022045Recalls & reported problems
Smith & Nephew Medical Limited · PICO 15cm x 15cm US CTN1 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05000223495411), received between Apr 22, 2021 and Jun 24, 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
Device problems
- Pumping Stopped4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2021Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT DURING NPWT, THE PICO 14 15CM X 15CM PUMP HAD ALL FOUR LIGHTS STAY LIT. THE TREATMENT WAS COMPLETED WITH ANOTHER PUMP. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12059409 ↗MalfunctionApr 22, 2021Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT DURING NPWT, THE PICO 14 15CM X 15CM PUMP HAD ALL FOUR LIGHTS STAY LIT. THE TREATMENT WAS COMPLETED WITH ANOTHER PUMP. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712133 ↗MalfunctionApr 22, 2021Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT DURING NPWT, THE PICO 14 15CM X 15CM PUMP HAD ALL FOUR LIGHTS STAY LIT. THE TREATMENT WAS COMPLETED WITH ANOTHER PUMP. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712117 ↗MalfunctionApr 22, 2021Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT DURING NPWT, THE PICO 14 15CM X 15CM PUMP HAD ALL FOUR LIGHTS STAY LIT. THE TREATMENT WAS COMPLETED WITH ANOTHER PUMP. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11712116 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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