Renaflo II Hemofilter HF 1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00677964000089), received between Feb 21, 2018 and Jan 21, 2022 — classified as 2 deaths, 31 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE INVOLVING THE MEDIVATORS HF1200 HEMOFILTER, A FILTER LEAK OCCURRED. THE REPORTED FILTER LEAK RESULTED IN AN APPROXIMATELY 100ML VOLUME OF PATIENT BLOOD LOST. THE FILTER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAYS. NO ADDITIONAL REPORTS OF MALFUNCTION OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13322935 ↗
• MalfunctionJan 21, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE INVOLVING THE MEDIVATORS HF1200 HEMOFILTER, A FILTER LEAK OCCURRED. THE REPORTED FILTER LEAK RESULTED IN AN APPROXIMATELY 100ML VOLUME OF PATIENT BLOOD LOST. THE FILTER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAYS. NO ADDITIONAL REPORTS OF MALFUNCTION OR INJURY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13320388 ↗
• DeathJan 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  (B)(4), A DISTRIBUTOR OF MEDIVATORS HEMOFILTERS, REPORTED THAT DURING A HEMOFILTRATION PROCEDURE INVOLVING THE MEDIVATORS HF1200 HEMOFILTER, A FILTER LEAK OCCURRED. A SECOND FILTER WAS PREPPED TO BE EXCHANGED IN ORDER TO CONTINUE THE PROCEDURE. DURING THE PREPARATION OF THE SECOND FILTER, THE PATIENT EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 13181365 ↗
• MalfunctionJan 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  NIKKISO, A DISTRIBUTOR OF MEDIVATORS HEMOFILTERS, REPORTED THAT DURING A HEMOFILTRATION PROCEDURE INVOLVING THE MEDIVATORS HF1200 HEMOFILTER, A FILTER LEAK OCCURRED. A PATIENT BLOOD LOSS OF APPROXIMATELY 100ML WAS REPORTED. THE PATIENT WAS ADDITIONALLY REPORTED TO HAVE DEVELOPED "ALLERGIC-LIKE" SYMPTOMS INCLUDING CHILLS, PALPITATION AND SWEATING. THE FILTER SUBJECT OF THE EVENT WAS EXCHANGED, AND ALL SYMPTOMS WERE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PATIENT CONSEQUENCES REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13177417 ↗
• MalfunctionJan 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE INVOLVING THE MEDIVATORS HF1200 HEMOFILTER, A FILTER LEAK OCCURRED. THE FILTER LEAK RESULTED IN A 100ML VOLUME OF PATIENT BLOOD LOSS. THE FILTER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAYS. NO REPORTS OF INJURY OR HARM WERE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177407 ↗
• MalfunctionDec 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE INVOLVING THE MEDIVATORS HF1200 HEMOFILTER, A FILTER LEAK OCCURRED. THE FILTER LEAK RESULTED IN A 200ML VOLUME OF PATIENT BLOOD LOSS. THE FILTER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAYS. NO ADDITIONAL REPORTS OF INJURY OR HARM WERE RECEIVED FOR THIS PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13047628 ↗
• MalfunctionOct 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF 1200 HEMOFILTER, A FIBER LEAK OCCURRED DURING A PATIENT PROCEDURE RESULTING IN APPROXIMATELY 100ML OF PATIENT BLOOD LOSS. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOM AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681645 ↗
• MalfunctionOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF1200 HEMOFILTER, A FIBER LEAK OCCURRED WHICH RESULTED IN APPROXIMATELY 100 ML OF PATIENT BLOOD LOSS. THERE WAS NO PATIENT HARM REPORTED. NO MEDICAL INTERVENTION WAS SOUGHT AND NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586246 ↗
• MalfunctionOct 6, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF1200 HEMOFILTER, A FIBER LEAK OCCURRED WHICH RESULTED IN APPROXIMATELY 100 ML OF PATIENT BLOOD LOSS. THERE WAS NO PATIENT HARM REPORTED. NO MEDICAL INTERVENTION WAS SOUGHT AND NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584883 ↗
• MalfunctionSep 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF1200 HEMOFILTER, A FIBER LEAK OCCURRED WHICH RESULTED IN APPROXIMATELY 173 ML OF PATIENT BLOOD LOSS. THERE WAS NO HARM TO THE PATIENT REPORTED. NO MEDICAL INTERVENTION WAS SOUGHT AND NO ADVERSE PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526709 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF 1200 HEMOFILTER, A PATIENT LOST APPROXIMATELY 100ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOM AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307590 ↗
• MalfunctionAug 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF 1200 HEMOFILTER, A FIBER LEAK OCCURRED ABOUT 1 HOUR INTO THE PROCEDURE RESULTING IN APPROXIMATELY 100ML OF PATIENT BLOOD LOSS. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOM AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307511 ↗
• MalfunctionJul 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF 1200 HEMOFILTER, A PATIENT LOST APPROXIMATELY 100ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOM AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12241567 ↗
• MalfunctionJul 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF 1200 HEMOFILTER, A PATIENT LOST APPROXIMATELY 200ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOM AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204197 ↗
• InjuryMay 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF 1200 HEMOFILTER, A PATIENT LOST APPROXIMATELY 100CC OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11821143 ↗
• InjuryMar 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 200CC OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11401364 ↗
• InjuryDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT WHILE USING THE MEDIVATORS HF-1200, A PATIENT LOST APPROXIMATELY 200CC OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10953653 ↗
• MalfunctionJun 10, 2020Break; Break

  IT WAS REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 100ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Blood Loss

  MAUDE report 10140996 ↗
• MalfunctionMay 28, 2020Break; Break

  IT WAS REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 100ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Blood Loss

  MAUDE report 10096013 ↗
• MalfunctionMay 28, 2020Break; Break

  IT WAS REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 100ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Blood Loss

  MAUDE report 10096012 ↗
• InjuryMay 22, 2019Break; Break

  (B)(4), DISTRIBUTOR OF HEMOFILTERS IN (B)(6), REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 200ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Blood Loss

  MAUDE report 8633041 ↗
• DeathMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE INITIALLY REPORTED INFORMATION AND ADDITIONAL DETAILS PROVIDED FOR THIS EVENT, IT HAS BEEN CONFIRMED THAT THE PATIENT WAS SEPTIC PRIOR TO THE HF 1200 HEMOFILTRATION PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED A FIBER LEAK OCCURRED, INDICATING THAT BLOOD WAS IDENTIFIED AS LEAKING FROM ONE OR MORE FIBERS AND WAS CAPTURED WITHIN THE FILTER CASING. A FIBER LEAK IS VISUALLY DETECTABLE BY THE OPERATOR. THE TIME AT WHICH THE LEAK OCCURRED DURING THE PROCEDURE WAS NOT DISCLOSED. THE PATIENT WAS REPORTED TO BE NEAR DEATH AND THE DECISION WAS MADE BY THE FACILITY AND PATIENT'S FAMILY TO SEND HIM HOME WHERE HE EXPIRED. IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED. GIVEN THE STATUS OF THE PATIENT BEING SEPTIC PRIOR TO THE HEMOFILTRATION PROCEDURE, AND THE RESULTS OF THE INVESTIGATION, IT IS BELIEVED THAT THE PATIENT OUTCOME IS UNLIKELY TO BE RELATED TO THE HF 1200 AND/OR REPORTED FIBER LEAK.

  Patient problems: Death

  MAUDE report 8632573 ↗
• InjuryMay 17, 2019Break; Break

  (B)(4), DISTRIBUTOR OF HEMOFILTERS IN (B)(6), REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 110ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Blood Loss

  MAUDE report 8621769 ↗
• InjuryMay 13, 2019Break; Break

  NIKKISO, DISTRIBUTOR OF HEMOFILTERS IN (B)(4), REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 120ML OF BLOOD. IT WAS REPORTED THE THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Blood Loss

  MAUDE report 8604555 ↗
• InjuryMay 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  NIKKISO, DISTRIBUTOR OF HEMOFILTERS IN (B)(4), REPORTED THAT WHILE A FACILITY WAS USING THE MEDIVATORS HF 1200, A PATIENT LOST APPROXIMATELY 200ML OF BLOOD. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AS A RESULT OF THE BLOOD LOSS AND NO ADDITIONAL MEDICAL INTERVENTION WAS SOUGHT.

  Patient problems: Blood Loss

  MAUDE report 8604439 ↗