LibertyRecalls & reported problems across all models
Fresenius Medical Care Holdings, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11,598
- Deaths reported
- 30
- Injuries reported
- 3,772
- Recalls
- 1
We found 5 models of Liberty by Fresenius Medical Care Holdings, Inc. in the FDA's device registry (GUDID). Together they are named in 11,598 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2015 and Sep 30, 2026 — classified as 30 deaths, 3,772 injuries, 7,795 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (7,800 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Liberty recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 28, 2021Class IITerminated
Exposed to freezing temperatures due to refrigerated truck malfunctions
Z-2085-2021 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported Liberty problems
Device problems
- Fluid/Blood Leak7,800
- Adverse Event Without Identified Device or Use Problem3,743
- Disconnection52
- Device Handling Problem28
- Hole In Material21
- Leak/Splash7
- Material Puncture/Hole7
- Loose or Intermittent Connection6
Patient problems
- No Known Impact Or Consequence To Patient4,276
- Peritonitis3,704
- No Clinical Signs, Symptoms or Conditions3,455
- Abdominal Pain1,919
- Nausea194
- Peritoneal effluent abnormal188
- Vomiting154
- Fever113
Liberty models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Liberty® 050-87216SYSTEM, PERITONEAL, AUTOMATIC DELIVERY16 deaths9,148 reports
- Liberty® 050-87212SYSTEM, PERITONEAL, AUTOMATIC DELIVERY12 deaths2,169 reports
- Liberty® 050-87215SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 death279 reports
- Liberty® 026-20036ASystem, Peritoneal, Automatic Delivery1 recall1 report
- Liberty® 026-20226SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 death1 report
Recent Liberty adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis
MAUDE report 50954691 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Nausea; Peritonitis; Unspecified Gastrointestinal Problem; Vomiting
MAUDE report 50950008 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacteremia; Chills; Fever; Peritonitis
MAUDE report 50949678 ↗DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem
During follow-up for drain complications, it was reported that this peritoneal dialysis (PD) patient passed away. Additional information was obtained through follow-up with the charge nurse at the PD clinic. The patient had been admitted to the hospital on (B)(6) 2026 with a diagnosis of sepsis. PD effluent and cell count were drawn on either (B)(6) 2026 or (B)(6) 2026 which resulted positive for peritonitis. The culture results were not available. There was also concern for calciphylaxis. A biopsy had been scheduled. No information pertaining to antibiotics was available. On (B)(6) 2026, the patient¿s sister was present in the hospital with the patient and stated the patient ¿stopped breathing¿. The patient was a do not resuscitate (DNR), so no resuscitative efforts were performed. The cause of death was cardiac arrest. The patient¿s death was not related to any FME device, drug, product or dialysis treatment. It is unknown if the patient continued dialysis during the hospitalization. The cause of the peritonitis event is unknown. The patient had a prior history of myocardial infarctions, chronic obstructive pulmonary disease (COPD), diabetes mellitus (DM), and possible calciphyla
Patient problems: Cardiac Arrest; Peritonitis; Sepsis
MAUDE report 50937423 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Peritonitis
MAUDE report 50936969 ↗MalfunctionSep 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936641 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abdominal Pain; Peritonitis; Vomiting
MAUDE report 50925239 ↗InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abdominal Pain; Chills; Fever; Nausea; Peritoneal effluent abnormal; Peritonitis; Vomiting
MAUDE report 50908446 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis
MAUDE report 50904764 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis
MAUDE report 50904116 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis
MAUDE report 50903974 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis
MAUDE report 50903519 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888572 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
A nurse reported a patient with renal failure (RF) on continuous cyclic peritoneal dialysis "[CC(PD)]" utilizing a Liberty Select Cycler and Liberty Cycler Set for renal replacement therapy (RRT) was hospitalized for peritonitis due to user error. Follow-up with the patient¿s primary PD registered nurse (PDRN) verified the patient presented to the emergency room on (b)(6) 2026 with complaints of abdominal pain and cloudy peritoneal effluent fluid. A peritoneal effluent fluid culture and cell count (WBC elevated, result not provided) were collected, and the patient was formally admitted. The patient was diagnosed with peritonitis and was treated with intraperitoneal (IP) Vancomycin every 5 days, and Ceftazidime daily for 21 days. The patient¿s peritoneal effluent culture result returned positive for Methicillin Resistant Staphylococcus aureus on (b)(6) 2026, and the patient¿s Ceftazidime was discontinued. The patient continued to undergo CCPD therapy while hospitalized and is recovering from the serious adverse events. On (b)(6) 2026, the patient was sent to a rehabilitation hospital for strength training and occupational therapy. The patient continues to utilize his personal Libert
Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis
MAUDE report 50885177 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that this male peritoneal dialysis (PD) patient was diagnosed with peritonitis. The patient transitioned to in-center hemodialysis. Additional information was obtained through follow-up with the patient¿s peritoneal dialysis registered nurse (PDRN). The patient was initially diagnosed with peritonitis on (b)(6) 2026. The patient was experiencing abdominal pain and cloudy PD fluid. The patient went to the emergency room (ER) to have cultures drawn. The patient was diagnosed with peritonitis and subsequently admitted to the hospital. The patient was initially started on antibiotic therapy with intraperitoneal (IP) Vancomycin and Ceftazidime (dose, frequency, and duration unknown). The culture results were not received from the hospital, but the physician documented them as positive for Acinetobacter (no species). The patient¿s antibiotics were changed to Gentamicin (dose, frequency, and duration unknown). The patient was discharged on (b)(6) 2026 and they completed the antibiotic regimen. The patient was then seen at the PD clinic on (b)(6) 2026 due to cloudy PD fluid. The patient had PD cultures obtained. The patient was started on antibiotic therapy with intraperito
Patient problems: Abdominal Pain; Peritoneal effluent abnormal; Peritonitis
MAUDE report 50883809 ↗
Other Fresenius Medical Care Holdings, Inc. products
- Optiflux9 models · 5,700 reports · 3 recalls
- 2008T BlueStar Hemodialysis Machine4 models · 767 reports · 11 recalls
- CombiSet10 models · 819 reports · 1 recall
- stay.safe8 models · 187 reports · 6 recalls
- NaturaLyte2 models · 25 reports · 1 recall
- Bibag2 models · 0 reports · 1 recall
- Crit-Line2 models · 30 reports
- Hemoflow4 models · 29 reports
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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