Invia LibertyRecalls & reported problems
Medela AG · Negative Pressure Wound Therapy Powered Suction Pump 087.0000 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07612367015578), received between Apr 17, 2020 and May 24, 2022 — classified as 8 injuries.
The most frequently reported specific device problem is “Gas/Air Leak” (2 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
- Gas/Air Leak2
- Patient-Device Incompatibility2
- Device Alarm System1
- Energy Output Problem1
- Image Display Error/Artifact1
- Obstruction of Flow1
- Protective Measures Problem1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- Unspecified Infection4
- Insufficient Information3
- Local Reaction1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2022Energy Output Problem; Obstruction of Flow
ON (B)(6) 2022 THE CUSTOMER ALLEGED TO MEDELA LLC THAT THEY HAD A SYSTEM CLOGGED ALARM WHILE USING THE MEDELA LIBERTY NEGATIVE PRESSURE WOUND THERAPY PUMP. ADDITIONALLY, THE MOTHER STATES THERE IS NOTHING WRONG WITH THE DRESSING ON THE PUMP, THEY NEED MORE CANISTERS TO BE DELIVERED TO THE HOSPITAL, AS THE PATIENT IS BEING ADMITTED TO THE HOSPITAL FOR A BLOOD INFECTION. THE NURSE EXPLAINED THAT THE DEVICE MAY BE REMOVED BECAUSE THEY MAY CHANGE THE PLAN OF CARE WHILE IN THE HOSPITAL. THE MOTHER STATES THAT NO ONE CAN DO THE DRESSING CHANGE BUT THE SURGEON. HE HAS TO COME TO THE HOSPITAL EACH TIME TO HAVE THE DRESSING CHANGED. ON (B)(6) 2022, A SECOND CALL FROM THE MOTHER TONIGHT AND SHE STATES THAT THERE WAS AN ALARM AND THE PUMP WENT OUT. SHE DOES NOT KNOW WHAT TYPE OF ALARM, AND THE DEVICE IS NOT LONGER CONNECTED TO THE PATIENT. SHE REFUSED TO RECONNECT THE PATIENT TO THE UNIT TO TROUBLESHOOT. STATES THAT THE SURGEON IS THE ONLY PERSON THAT CAN CONNECT THE PUMP TO THE PATIENT. SHE SAYS THE SURGEON IS NOT AVAILABLE TO TROUBLESHOOT WITH THEM, SURGEON HAS ALREADY LEFT THE ROOM. THIS NURSE EXPLAINED TO THE MOTHER THAT IT IS LIKELY THAT THE ISSUE IS NOT THE DEVICE BECAUSE IT IS NOT LIKE
Patient problems: Unspecified Infection
MAUDE report 14488943 ↗InjuryJan 6, 2022Gas/Air Leak; Protective Measures Problem
ON (B)(6) 2021 THE PATIENT CALLED IN TO MEDELA LLC AND ALLEGED THAT THE LIBERTY NEGATIVE PRESSURE WOUND VACUUM HAD BEEN TURNED OFF TWO DAYS AGO DUE TO AN AIR LEAK ALARM, WHICH THE PATIENTS' NURSE STATED LED TO A WOUND INFECTION. HE ADDITIONALLY ALLEGED THAT HE WAS BEING TREATED IN THE HOSPITAL WITH ANTIBIOTICS FOR THE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13181013 ↗InjurySep 17, 2021Patient-Device Incompatibility
ON (B)(6) 2021 THE CUSTOMER ALLEGED TO MEDELA LLC THAT THEY HAD GOTTEN AN INFECTION WHILE USING THE MEDELA LIBERTY NEGATIVE PRESSURE WOUND THERAPY PUMP AND HAD GONE TO THE DOCTOR WHO PRESCRIBED ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 12489526 ↗InjurySep 17, 2021Patient-Device Incompatibility
ON 08/30/2021, THE NURSE AT (B)(6) HOSPITAL CONTACTED MEDELA LLC AND ALLEGED THAT THE PATIENT HAD A POSSIBLE ALLERGIC REACTION FROM THE FILM AT FOUR WOUND SITES WHILE USING THE LIBERTY NEGATIVE PRESSURE WOUND THERAPY PUMP.
Patient problems: Local Reaction
MAUDE report 12487811 ↗InjurySep 10, 2021Therapeutic or Diagnostic Output Failure
ON (B)(6) 2021, MEDELA LLC WAS MADE AWARE THAT THE PATIENT'S LIBERTY PUMP WAS NOT WORKING LIKE IT WAS SUPPOSED TO. THERE WAS A CONTAINER ISSUE.
Patient problems: Insufficient Information
MAUDE report 12453000 ↗InjuryAug 6, 2021Image Display Error/Artifact
ON (B)(6) 2021, THE CUSTOMER CONTACTED (B)(4), A MEDELA DISTRIBUTOR, AND ALLEGED THAT THE DISPLAY ON THE LIBERTY NEGATIVE PRESSURE WOUND THERAPY PUMP WAS NOT WORKING CORRECTLY. (B)(4) WAS TRANSFERRING THE CUSTOMER TO MEDELA WHEN THE CUSTOMER HUNG UP.
Patient problems: Insufficient Information
MAUDE report 12286603 ↗InjurySep 21, 2020Gas/Air Leak
ON (B)(6) 2020, A CUSTOMER ALLEGED TO MEDELA LLC THAT THE LIBERTY NEGATIVE PRESSURE WOUND THERAPY DEVICE GENERATED AN AIR LEAK.
Patient problems: Insufficient Information
MAUDE report 10560355 ↗InjuryApr 17, 2020Device Alarm System
ON 03/25/2020, A CUSTOMER ALLEGED TO MEDELA LLC THAT THE LIBERTY NEGATIVE PRESSURE WOUND THERAPY DEVICE WHICH WAS PLACED ON HER FATHER GENERATED A "SYSTEM CLOGGED" ALARM ON (B)(6) 2020 AND FLUID WAS NOT MOVING FROM THE DRESSING. SHE FURTHER ALLEGED THAT HER FATHER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 AND PLACED ON IV ANTIBIOTICS FOR AN INFECTION CAUSED BY THE DEVICE NOT WORKING.
Patient problems: Unspecified Infection
MAUDE report 9973203 ↗
Other Negative Pressure Wound Therapy Powered Suction Pump devices
- ACTIV.A.C. ™ iOn PROGRESS™ RTMGSM01/USKci USA, Inc. · Negative Pressure Wound Therapy Powered Suction Pump11 deaths472 reports
- RENASYS GO v2 HOME 66801496Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump424 reports
- RENASYS GO 66021496Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump278 reports
- RENASYS TOUCH 66801280Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump108 reports
- RENASYS EDGE 66803126Smith & Nephew Medical Limited · Negative Pressure Wound Therapy Powered Suction Pump1 recall28 reports
- PREVENA RESTOR™ BELLA•FORM™ PRE5355Kci USA, Inc. · Negative Pressure Wound Therapy Powered Suction Pump1 recall1 report
- Prevena Plus™ PRE4000USKci USA, Inc. · Negative Pressure Wound Therapy Powered Suction Pump1 recall1 report
- PREVENA RESTOR™ BELLA•FORM™ PRE5455Kci USA, Inc. · Negative Pressure Wound Therapy Powered Suction Pump1 recall0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page