PICO 66022004Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05000223492199), received between Jan 4, 2021 and May 20, 2021 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT, DURING NPWT, A PICO 7 10CMX40CM SYSTEM WAS UNABLE TO MAKE PROPER SEAL. NO SIGNIFICANT DELAY IN TREATMENT DUE TO THIS MALFUNCTION WAS REPORTED; NEVERTHELESS, TREATMENT WAS CONCLUDED WITH A COMPETITORS DRESSING. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11853534 ↗
• InjuryFeb 23, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING TREATMENT, 4 DIFFERENT PICO PUMPS WERE OPENED FOR THE SAME PATIENT. THE PUMP WOULD TURN GREEN, THEN ALMOST IMMEDIATELY ALL 4 LIGHTS WOULD ILLUMINATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366214 ↗
• MalfunctionJan 7, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP FAILED OUT OF THE BOX. THE CUSTOMER STATED THAT ALL 4 LIGHTS WERE ILLUMINATED. THE ISSUE WAS SOLVED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131460 ↗
• MalfunctionJan 7, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP FAILED OUT OF THE BOX. THE CUSTOMER STATED THAT ALL 4 LIGHTS WERE ILLUMINATED. THE ISSUE WAS SOLVED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131454 ↗
• InjuryJan 4, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING TREATMENT THE PICO PUMP FAILED, WITH ALL 4 LIGHTS REMAINING ON. A BACKUP WAS AVAILABLE TO CONTINUE TREATMENT WITH A MINIMUM DELAY OF LESS THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11112975 ↗
• InjuryJan 4, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING TREATMENT THE PICO PUMP FAILED, WITH ALL 4 LIGHTS REMAINING ON. A BACKUP WAS AVAILABLE TO CONTINUE TREATMENT WITH A MINIMUM DELAY OF LESS THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11112758 ↗
• MalfunctionJan 4, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING TREATMENT THE PICO PUMP FAILED, WITH ALL 4 LIGHTS REMAINING ON. A BACKUP WAS AVAILABLE TO CONTINUE TREATMENT WITH A MINIMUM DELAY OF LESS THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11112743 ↗