PICORecalls & reported problems across all models
Smith & Nephew Medical Limited · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 67
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls
- 0
We found 13 models of PICO by Smith & Nephew Medical Limited in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between May 24, 2020 and Feb 26, 2026 — classified as 15 injuries, 52 malfunctions.
The most frequently reported specific device problem is “Pumping Stopped” (45 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PICO problems
Device problems
- Pumping Stopped45
- Suction Failure8
- Adverse Event Without Identified Device or Use Problem7
- Defective Device2
- Failure to Pump2
- Pressure Problem2
- Biocompatibility1
- Device Alarm System1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient12
- No Known Impact Or Consequence To Patient9
- Blister2
- No Patient Involvement2
- Post Operative Wound Infection2
- Wound Dehiscence2
- Eczema1
PICO models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PICO 66800951Negative Pressure Wound Therapy Powered Suction Pump13 reports
- PICO 66022003Negative Pressure Wound Therapy Powered Suction Pump13 reports
- PICO 66022002Negative Pressure Wound Therapy Powered Suction Pump10 reports
- PICO 66022004Negative Pressure Wound Therapy Powered Suction Pump7 reports
- PICO 66800952Negative Pressure Wound Therapy Powered Suction Pump6 reports
- PICO 66022006Negative Pressure Wound Therapy Powered Suction Pump4 reports
- PICO 66002006Negative Pressure Wound Therapy Powered Suction Pump4 reports
- PICO 66800954Negative Pressure Wound Therapy Powered Suction Pump3 reports
- PICO 66022005Negative Pressure Wound Therapy Powered Suction Pump3 reports
- PICO 66800953Negative Pressure Wound Therapy Powered Suction Pump1 report
- PICO 66022012Negative Pressure Wound Therapy Powered Suction Pump1 report
- PICO 66002002Negative Pressure Wound Therapy Powered Suction Pump1 report
- PICO 66022031Negative Pressure Wound Therapy Powered Suction Pump1 report
Recent PICO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2026Leak/Splash; Biocompatibility
IT WAS REPORTED THAT, DURING NPWT, PATIENT EXPERIENCED ITCHING AND BLISTERS USING THE PICO 7 SINGLE DRESSING 10CM X 20CM. THIS ADVERSE EVENT WAS ADDRESSED WITH ROUND-THE-CLOCK MAXIMUM DOSES OF IV AND ORAL ANTIHISTAMINES (FOR THE ALLERGIC REACTION), PLUS PAIN MEDICATION (INCLUDING NORCO) WHICH ALLOWED TO PATIENT TO TOLERATE IT AT THE TIME. PATIENT USED A SECOND PICO, THREAE-DAYS POST HOSPITAL DISCHARGE. SHE HOPED TO CONTROL ANY RECURRENCE AT HOME USING ORAL ANTIHISTAMINES (ATARAX, ZYRTEC, AND BENADRYL) AND TOPICAL BENADRYL CREAM. UPON ARRIVAL TO HOME, PATIENT TOOK ATARAX WITH MINIMAL RELIEF AND THEN, 25 MG OF BENADRYL WHICH LED TO COMPLETE SEDATION. ALTHOUGH, PATIENT WOKE UP DUE TO CONTINUED PUMP CYCLING; THE SEAL BROKE FROM RAISED HIVES/WELTS AND THE PUMP INDICATOR CHANGED TO ORANGE (LEAK DETECTED) AS CONSEQUENCE SHE TOOK ADDITIONAL 50MG OF BENADRYL. AT THIS STAGE, PATIENT WAS EXPERIENCING INSANE, UNBEARABLE ITCHING; AND THE SKIN UNDER THE ADHESIVE WAS INFLAMED AND BLISTERED. ATARAX PROVIDED NO RELIEF AFTER 45 MINUTES. AFTER THIS, HUSBAND'S PATIENT REMOVED THE DRESSING AND APPLIED BENADRYL CREAM LIBERALLY WITH NO SIGNIFICANT RELIEF. THEN, THEY ATTEMPTED TO SALVAGE THE DRESSING BY A
Patient problems: Blister; Itching Sensation; Rash; Skin Inflammation/ Irritation; Urticaria
MAUDE report 24455356 ↗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 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER THA PERFORMED ON (B)(6) 2022, THE PATIENT FELL AND THE WOUND BECAME DEHISCED. A PICO 7 WAS APPLIED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED ON (B)(6)2022. WHEN THE DRESSING WAS SATURATED THE HOMECARE NURSE APPLIED ALLEVYN ADHESIVE AND COVERS THE DRESSING WITH PICO 7. ON (B)(6) 2022 PATIENT RETURNS TO HOSPITAL AND THERE IS A SUSPICION OF MILD INFECTION. ON (B)(6)2022, PATIENT REOPERATED DUE TO DEEP INFECTION. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 13870466 ↗InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER NPWT UTILIZING A PICO 7 10CM X 20CM, THE PATIENT HAD TO UNDERGO FURTHER AMPUTATION/OPERATION, AND IS BLAMING THE NURSE AND THE DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12831801 ↗MalfunctionAug 13, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED DURING A NWPT, THAT THE PATIENT WAS OUTSIDE SMOKING, NOTICED THAT THE PICO SINGLE USE NPWT 10X20CM TUBING WAS CUT OFF AND THERE WAS A BURNING SITE. PATIENT IS PRETTY SURE THAT IT DIDN'T CAME FROM CIGARETTE. TREATMENT WAS RESUMED WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12321141 ↗MalfunctionJun 29, 2021Pumping Stopped; Pumping Stopped
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 12089576 ↗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 ↗MalfunctionJun 2, 2021Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT DURING SET UP FOR TREATMENT THE PICO SINGLE USE NPWT 10X20CM WAS TURNED ON, ALL LIGHTS LIGHT UP AND THEN IT GOES DEAD AND WILL NOT WORK. HE TRIED DIFFERENT BATTERIES AND THE SAME ISSUE HAPPENED. THE TREATMENT WAS COMPLETED, WITH A MINIMAL DELAY (LESS THAN 30 MINUTES) USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11921134 ↗MalfunctionMay 25, 2021Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT DURING NPWT, THE PICO SINGLE USE NPWT 15 X 15CM WAS NOT LONGER FUNCTIONAL. THE BATTERY WAS CHANGED BUT THE ISSUE PERSIST. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11881070 ↗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 ↗MalfunctionApr 26, 2021Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT, AFTER TREATMENT WITH FOUR PICO 7 15CMX20CM THE PUMP STOPPED WORKING WITHIN AN HOUR. IT WAS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11726936 ↗
Other Smith & Nephew Medical Limited products
All Smith & Nephew Medical Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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