PICO 66800951Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05000223477073), received between May 24, 2020 and Aug 13, 2021 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionApr 21, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING TREATMENT THE 2ND DAY PICO SINGLE USE NPWT 10X20CM STOPPED WORKING. IN ADDITION, BATTERIES OF THE DEVICE CHANGED BUT STILL DIDN'T WORK. THE PATIENT USED DRESSINGS FOR 2 DAYS AND LATER THE TREATMENT WAS RESUME WITH A S&N BACK UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701322 ↗
• InjuryApr 19, 2021Device Alarm System; Device Alarm System

  THE NURSE IN QUESTION PLACED THE PICO DRESSING ON THE PATIENT AND WAITED TILL THE PUMP WENT GREEN. A FEW SECONDS LATER THE RED LIGHT CAME ON AND STAYED ON, THE NURSE CHANGED THE DRESSING AND SAME THING HAPPENED AGAIN. THERE WAS NO DELAY, NO HARM OR INJURY REPORTED AND THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11684629 ↗
• MalfunctionNov 10, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A PICO 7 HAVE ALL THE LIGHTS LIT. THEY DON`T GO OUT AND IT`S NOT POSSIBLE TO START THE TREATMENT OR TURN OFF THE PUMP. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10820221 ↗
• MalfunctionSep 17, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED, AFTER PROCEDURE WHEN PUT BATTERIES IN PUMP AND ALL OF THE LIGHTS CAME ON, NEVER TURNED OFF, AND PUMP WOULD NOT APPLY NEGATIVE PRESSURE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10550535 ↗
• MalfunctionJun 29, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A PICO PUMP WORKED AS IT SHOULD FOR ABOUT A DAY BUT THEN IT MADE A LOUD SCREECHING SOUND AND COULD NOT ACHIEVE VACUUM. THE DRESSING FULL LIGHT WAS DISPLAYED EVEN WHEN THE PUMP WAS NOT CONNECTED TO THE DRESSING. THE PATIENT HAD TO DO EXTRA VISITS AT THE HOSPITAL FOR RESCHEDULING, SO THERE WAS A GREAT DELAY OF AT LEAST 2H IN THE PROCEDURE. THE TREATMENT CONTINUED WITH A BACK-UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10205522 ↗
• MalfunctionJun 29, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A PICO PUMP WORKED AS IT SHOULD FOR ABOUT A DAY BUT THEN IT MADE A LOUD SCREECHING SOUND AND COULD NOT ACHIEVE VACUUM. THE DRESSING FULL LIGHT WAS DISPLAYED EVEN WHEN THE PUMP WAS NOT CONNECTED TO THE DRESSING. THE PATIENT HAD TO DO EXTRA VISITS AT THE HOSPITAL FOR RESCHEDULING, SO THERE WAS A GREAT DELAY OF AT LEAST 2H IN THE PROCEDURE. THE TREATMENT CONTINUED WITH A BACK-UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10205515 ↗
• MalfunctionJun 29, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A PICO PUMP WORKED AS IT SHOULD FOR ABOUT A DAY BUT THEN IT MADE A LOUD SCREECHING SOUND AND COULD NOT ACHIEVE VACUUM. THE DRESSING FULL LIGHT WAS DISPLAYED EVEN WHEN THE PUMP WAS NOT CONNECTED TO THE DRESSING. THE PATIENT HAD TO DO EXTRA VISITS AT THE HOSPITAL FOR RESCHEDULING, SO THERE WAS A GREAT DELAY OF AT LEAST 2H IN THE PROCEDURE. THE TREATMENT CONTINUED WITH A BACK-UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10205481 ↗
• MalfunctionJun 29, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A PICO PUMP WORKED AS IT SHOULD FOR ABOUT A DAY BUT THEN IT MADE A LOUD SCREECHING SOUND AND COULD NOT ACHIEVE VACUUM. THE DRESSING FULL LIGHT WAS DISPLAYED EVEN WHEN THE PUMP WAS NOT CONNECTED TO THE DRESSING. THE PATIENT HAD TO DO EXTRA VISITS AT THE HOSPITAL FOR RESCHEDULING, SO THERE WAS A GREAT DELAY OF AT LEAST 2H IN THE PROCEDURE. THE TREATMENT CONTINUED WITH A BACK-UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10205393 ↗
• MalfunctionJun 23, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THE PICO PUMP WORKED AS IT SHOULD FOR ABOUT A DAY BUT THEN IT MADE A LOUD SCREECHING SOUND AND COULD NOT ACHIEVE VACUUM. THE DRESSING FULL LIGHT WAS DISPLAYED EVEN WHEN THE PUMP WAS NOT CONNECTED TO THE DRESSING. THE PATIENT HAD TO DO EXTRA VISITS AT THE HOSPITAL FOR RESCHEDULING, SO THERE WAS A GREAT DELAY OF AT LEAST 2H IN THE PROCEDURE. THE TREATMENT CONTINUED WITH A BACK-UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183126 ↗
• MalfunctionJun 23, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THE PICO PUMP WORKED AS IT SHOULD FOR ABOUT A DAY BUT THEN IT MADE A LOUD SCREECHING SOUND AND COULD NOT ACHIEVE VACUUM. THE DRESSING FULL LIGHT WAS DISPLAYED EVEN WHEN THE PUMP WAS NOT CONNECTED TO THE DRESSING. THE PATIENT HAD TO DO EXTRA VISITS AT THE HOSPITAL FOR RESCHEDULING, SO THERE WAS A GREAT DELAY OF AT LEAST 2H IN THE PROCEDURE. THE TREATMENT CONTINUED WITH A BACK-UP DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10183120 ↗
• MalfunctionMay 24, 2020Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT DURING TREATMENT THE DEVICE TURNED ON ALL THE LIGHTS, STOPPED HAVING PRESSURE AND DID NOT WORK ANYMORE, PROBLEM APPEARED SUDDENLY. IT IS UNKNOWN HOW TREATMENT WAS COMPLETED. NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10084844 ↗