Renaflo II HemofilterRecalls & reported problems across all models

We found 2 models of Renaflo II Hemofilter by Medivators Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2018 and Jun 14, 2023 — classified as 2 deaths, 31 injuries, 17 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. 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

Most reported Renaflo II Hemofilter problems

Renaflo II Hemofilter models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Renaflo II Hemofilter HF 1200

  Dialyzer, High Permeability With Or Without Sealed Dialysate System
  2 deaths49 reports
• Renaflo II Hemofilter HF 400

  Dialyzer, High Permeability With Or Without Sealed Dialysate System
  1 report

Recent Renaflo II Hemofilter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED VIA MEDWATCH REPORT #MW5117414 THAT DURING A PATIENT PROCEDURE INVOLVING THE 400 RENAFLO II HEMOFILTER, A FILTER LEAK OCCURRED. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127608 ↗
• 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 ↗

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