PICO 66022003Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05000223492182), received between Jun 30, 2020 and Nov 3, 2025 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NPWT, A PICO 7 10CM X 30CM WAS USED FOR A CAESAREAN SECTION WOUND. AFTER 7 DAYS THE DRESSING WAS CHANGED FOR A FRESH ONE DUE TO AN ONGOING INFECTION, THE BATTERY PACK THEN STOPPED WORKING AS IT IS MEANT TO. THE WOUND INFECTION WAS TREATED WITH ORAL FLUCLOXACILLIN ON DAY 7, ON DAY 10, THE PATIENT WAS ADMITTED AND TREATED WITH IV FLUCLOXACILLIN AND METRONIDAZOLE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Wound Infection

  MAUDE report 23459997 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "EFFECTIVENESS OF SPECIFIC SINGLE-USE INCISIONAL NEGATIVE PRESSURE WOUND THERAPY (PICO SYSTEM) AFTER MAJOR LOWER EXTREMITY AMPUTATION", ONE (1) PATIENT SUFFERED FROM WOUND DEHISCENCE WHILE USING A PICO 7 (10 X 30 CM) DEVICE AFTER UNDERGOING A LOWER EXTREMITY AMPUTATION SURGERY. PATIENT WOUND HEALED NATURALLY WITHOUT REQUIRING ANY INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Wound Dehiscence

  MAUDE report 21913706 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "EFFECTIVENESS OF SPECIFIC SINGLE-USE INCISIONAL NEGATIVE PRESSURE WOUND THERAPY (PICO SYSTEM) AFTER MAJOR LOWER EXTREMITY AMPUTATION", ONE (1) PATIENT SUFFERED FROM SUPERFICIAL SURGICAL SITE INFECTION (SSI) WHILE USING A PICO 7 (10 X 30 CM) DEVICE AFTER UNDERGOING A LOWER EXTREMITY AMPUTATION SURGERY. PATIENT REQUIRED ANTIBIOTIC ADMINISTRATION. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21913688 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "EFFECTIVENESS OF SPECIFIC SINGLE-USE INCISIONAL NEGATIVE PRESSURE WOUND THERAPY (PICO SYSTEM) AFTER MAJOR LOWER EXTREMITY AMPUTATION", ONE (1) PATIENT SUFFERED FROM SUPERFICIAL SURGICAL SITE INFECTION (SSI) WITH WOUND DEHISCENCE WHILE USING A PICO 7 (10 X 30 CM) DEVICE AFTER UNDERGOING A LOWER EXTREMITY AMPUTATION SURGERY. PATIENT REQUIRED WOUND DEBRIDEMENT IN THE OPERATING ROOM. THE OUTCOME OF THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 21913645 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, WHEN REMOVING A PICO 7 10X30CM DURING A POST-OPERATIVE CHECK UP, IT WAS FOUND THAT THE PATIENT HAD LARGE BLISTER. A NEW DRESSING WAS APPLIED AND THEN THE PATIENT CAME BACK 7 DAYS LATER AND HAD A 6X6 WOUND WITH ESCHAR. AFTER THIS, PATIENT NEEDED IRRIGATION AND DEBRIDEMENT.

  Patient problems: Blister; Eczema; Impaired Healing; Necrosis

  MAUDE report 16063758 ↗
• MalfunctionJun 29, 2021Failure to Pump; Failure to Pump

  IT WAS REPORTED THAT, UPON INSERTION OF THE BATTERIES, A PICO 7 10CMX30CM WAS NOT ABLE TO START PUMPING AND ALL LIGHTS ILLUMINATED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVED DURING THIG ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089557 ↗
• MalfunctionMar 26, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE CUSTOMER HAS A PICO THAT DOESN'T WORK. WHEN THE BATTERIES ARE PLACED IN THE DEVICE, ALL OF THE LIGHTS COME ON IMMEDIATELY AND THEN TURN OFF. CUSTOMER REPLACED THE BATTERIES AND IT DID THE SAME THING. CUSTOMER EVEN HOOKED IT UP TO THE DRESSING AND IT DID NOT WORK. BACK UP WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574786 ↗
• MalfunctionFeb 17, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT AFTER INSERTING THE BATTERIES, ALL LIGHTS OF THE PICO DEVICE LIGHTED-UP AND THE DEVICE WOULDN'T START. NO PATIENT WAS INVOLVED SINCE THIS WAS AN OUT OF THE BOX FAILURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A SMALL DELAY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11340514 ↗
• MalfunctionNov 26, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE OR STAFF WAS PREPARING THE PICO DEVICE AND NOTICED THAT ALL THE LIGHTS WERE TURNED ON OUT-OF-BOX. THE ISSUE DID NOT RESOLVE BY PAUSING THERAPY OR REMOVING/REINSERTING THE BATTERIES. THE STAFF NOTIFIED THE S+N REP OF THE ISSUE. PROCEDURE FINISHED WITH S&N BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912509 ↗
• MalfunctionAug 13, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING TREATMENT WITH PICO 7 APPLIED POST-OP, THE PICO 7 DEVICE DID NOT OPERATE PROPERLY. WHEN THE BATTERIES WERE PLACED IN THE DEVICE ALL OF THE LIGHTS FLASHED ON AND FROZEN. WHEN THE OR STAFF TRIED TO PUSH THE ORANGE BUTTON, THE DEVICE WOULD NOT TURN ON AND THE LIGHTS REMAINED ON AND FROZEN. A SMALL DELAY WAS REPORTED WHILE GETTING A BACK-UP PICO KIT TO CONTINUE TREATMENT. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10402813 ↗
• MalfunctionJun 30, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT THREE PICO 7 DEVICES DID NOT OPERATE PROPERLY. WHEN THE BATTERIES WERE PLACED IN THE DEVICE ALL OF THE LIGHTS FLASHED ON AND FROZEN. WHEN THE OR STAFF TRIED TO PUSH THE ORANGE BUTTON, THE DEVICE WOULD NOT TURN ON AND THE LIGHTS REMAINED ON AND FROZEN. IT IS UNKNOWN IF A PATIENT WAS INVOLVED, IF THERE WAS A DELAY AND IF A ABACK-UP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213418 ↗
• MalfunctionJun 30, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT THREE PICO 7 DEVICES DID NOT OPERATE PROPERLY. WHEN THE BATTERIES WERE PLACED IN THE DEVICE ALL OF THE LIGHTS FLASHED ON AND FROZEN. WHEN THE OR STAFF TRIED TO PUSH THE ORANGE BUTTON, THE DEVICE WOULD NOT TURN ON AND THE LIGHTS REMAINED ON AND FROZEN. IT IS UNKNOWN IF A PATIENT WAS INVOLVED, IF THERE WAS A DELAY AND IF A ABACK-UP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213400 ↗
• MalfunctionJun 30, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT THREE PICO 7 DEVICES DID NOT OPERATE PROPERLY. WHEN THE BATTERIES WERE PLACED IN THE DEVICE ALL OF THE LIGHTS FLASHED ON AND FROZEN. WHEN THE OR STAFF TRIED TO PUSH THE ORANGE BUTTON, THE DEVICE WOULD NOT TURN ON AND THE LIGHTS REMAINED ON AND FROZEN. IT IS UNKNOWN IF A PATIENT WAS INVOLVED, IF THERE WAS A DELAY AND IF A BACK-UP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213060 ↗