LOW RECIRCULATION VOLUME APD SET N5C8305CRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00085412087672), received between Mar 16, 2018 and Jul 30, 2026 — classified as 60 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50089579 ↗
• MalfunctionJul 30, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50089576 ↗
• MalfunctionJul 30, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50089575 ↗
• MalfunctionJun 10, 2026Disconnection

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED DISCONNECTION ISSUE WITH AN UNSPECIFIED QUANTITY OF HOMECHOICE CASSETTES. THE PATIENT BECAME DISCONNECTED FROM TREATMENT. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT; HOWEVER, THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456644 ↗
• MalfunctionJun 8, 2026Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT LINE OF A HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE HAD A CONNECTION ISSUE WITH THE PATIENT¿S TRANSFER SET AND DISCONNECTED. THIS WAS DESCRIBED AS ¿THE PATIENT LINE FROM CASSETTE IS NOT CONNECTED WELL TO THE PATIENT'S TRANSFER SET¿ AND ¿THE PATIENT BECAME DISCONNECTED FROM THE MACHINE.¿ THIS OCCURRED DURING USE OF THE DEVICE FOR AUTOMATED PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT HOWEVER, THE PATIENT RECEIVED AN INSTALLATION OF PROPHYLACTIC ANTIBIOTICS, INTRAPERITONEALLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428628 ↗
• MalfunctionJan 20, 2026Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL SIX OF SEVEN OF PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS "FLUID ON THE FLOOR" AND ¿TUBING LEAK¿ THAT LED TO THIS ALARM, HOWEVER, NOT ABLE TO FIND THE LOCATION OF THE LEAK. RENAL THERAPY SERVICES (RTS) ASSISTED THE CAREGIVER (CG) TO END THE THERAPY SESSION AND REMOVE THE CASSETTE FROM THE DEVICE. RTS REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE CG. RTS ADVISED THE CG TO DRAIN USING MANUAL SUPPLIES AND TO CONTACT THE PATIENT'S PD REGISTERED NURSE FOR FURTHER INSTRUCTIONS REGARDING THE PATIENT¿S THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119496 ↗
• MalfunctionAug 15, 2024Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL EIGHT OF TEN OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. THE LEAK WAS FURTHER DESCRIBED AS "WHEN CLOSING THE CLAMPS, CAREGIVER (CG) NOTICED SOME WETNESS AT THE CONNECTION OF ONE OF THE SUPPLY BAGS AND THE SUPPLY LINE, CG DID NOT NOTICE ANY VISIBLE DAMAGE". RENAL THERAPY SERVICES (RTS) ASSISTED THE CG TO CLOSE THE TRANSFER SET AND DISCONNECT THE PATIENT USING THE ASEPTIC WAY. RTS REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE CG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992457 ↗
• MalfunctionJun 12, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE DRAIN LINE CAP OF THE HOMECHOICE CASSETTE WAS MISSING. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519728 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED THAT TWO (2) LOW RECIRCULATION VOLUME APD SET WITH CASSETTES WERE DAMAGED; FURTHER DESCRIBED AS ¿HAD A NICK ON THE SOLUTION LINE." THIS WAS OBSERVED DURING SET UP OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385244 ↗
• MalfunctionJan 8, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE SECOND LINE NEXT TO DOOR OF THE CYCLER HAD A PUNCTURE ON THE TUBING OF FIVE (5) HOME CHOICE CASSETTES WHICH RESULTED IN A LEAK. SOLUTION WAS FOUND UNDER THE CYCLER. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464853 ↗
• MalfunctionJan 8, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE SECOND LINE NEXT TO DOOR OF THE CYCLER HAD A PUNCTURE ON THE TUBING OF FIVE (5) HOMECHOICE CASSETTES WHICH RESULTED IN A LEAK. SOLUTION WAS FOUND UNDER THE CYCLER. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464852 ↗
• MalfunctionAug 1, 2023Crack; Fluid/Blood Leak; Protective Measures Problem; Crack; Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DRAIN EIGHT OF THIRTEEN OF PERITONEAL DIALYSIS (PD) THERAPY. DURING THE TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A CRACK IN THE HOMECHOICE CASSETTE WHICH RESULTED IN A LEAK FROM THE CORNER OF THE CASSETTE. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH CLEARING THE ALARM AND IN REMOVING THE SUPPLIES. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435205 ↗
• MalfunctionApr 4, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A PUNCTURED HOLE IN A LOW RECIRCULATION VOLUME APD SET WITH CASSETTE WHICH RESULTED IN A FLUID LEAK. THE PATIENT HAD COMPLETED PERITONEAL DIALYSIS (PD) THERAPY AND IT WAS DISCOVERED WHEN OPENING THE TRAY THAT THE CASSETTE WAS WET AND THERE WAS A PUNCTURED HOLE. THE NURSE STATED THAT ONLY THE CASSETTE WAS LEAKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS AS PRECAUTIONARY MEASURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675269 ↗
• MalfunctionFeb 21, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHAT APPEARED TO BE A "SMALL STYROFOAM BALL" WAS OBSERVED INSIDE THE TUBING "WITH A WHITE CLIP" OF THE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16407268 ↗
• MalfunctionJan 3, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE CAPS OF FOUR (4) TO FIVE (5) HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTES WERE NOT ON THE TOP OF THE TUBING; THE CAPS WERE REMOVED. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY, WHEN OPENING THE BAGS. THERE WAS NO DAMAGE NOTED ON THE SOLUTION AND DRAIN LINES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090097 ↗
• MalfunctionOct 31, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE HAD "HOLES IN ALL OF THE CASSETTE TUBING¿. THIS OCCURRED DURING PREPARATION OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699545 ↗
• MalfunctionOct 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED A LOW RECIRCULATION VOLUME APD SET WITH CASSETTE APPEARED DAMAGED. THE EVENT WAS FURTHER DESCRIBED AS THE DEVICES ¿EITHER HAD A NOTICEABLE SLICED HOLE OR A SCRATCH MARK VARYING IN SEVERITY¿. THE EVENT OCCURRED DURING UNSPECIFIED PROCESS STEP WHILE PERFORMING PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667559 ↗
• MalfunctionOct 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TWENTY-FIVE (25) LOW RECIRCULATION VOLUME APD SET WITH CASSETTES APPEARED DAMAGED. THE EVENT WAS FURTHER DESCRIBED AS THE DEVICES ¿EITHER HAD A NOTICEABLE SLICED HOLE OR A SCRATCH MARK VARYING IN SEVERITY¿. THE EVENTS OCCURRED DURING UNSPECIFIED PROCESS STEPS WHILE PERFORMING PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667501 ↗
• MalfunctionOct 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED A LOW RECIRCULATION VOLUME APD SET WITH CASSETTE APPEARED DAMAGED. THE EVENT WAS FURTHER DESCRIBED AS THE DEVICES ¿EITHER HAD A NOTICEABLE SLICED HOLE OR A SCRATCH MARK VARYING IN SEVERITY¿. THE EVENT OCCURRED DURING UNSPECIFIED PROCESS STEP WHILE PERFORMING PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667494 ↗
• MalfunctionOct 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED EIGHT (8) LOW RECIRCULATION VOLUME APD SET WITH CASSETTES APPEARED DAMAGED. THE EVENT WAS FURTHER DESCRIBED AS THE DEVICES ¿EITHER HAD A NOTICEABLE SLICED HOLE OR A SCRATCH MARK VARYING IN SEVERITY¿. THE EVENTS OCCURRED DURING UNSPECIFIED PROCESS STEPS WHILE PERFORMING PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667479 ↗
• MalfunctionOct 25, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED ELEVEN (11) LOW RECIRCULATION VOLUME APD SET WITH CASSETTES APPEARED DAMAGED. THE EVENT WAS FURTHER DESCRIBED AS THE DEVICES ¿EITHER HAD A NOTICEABLE SLICED HOLE OR A SCRATCH MARK VARYING IN SEVERITY¿. THE EVENTS OCCURRED DURING UNSPECIFIED PROCESS STEPS WHILE PERFORMING PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667477 ↗
• MalfunctionOct 17, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED AN UNKNOWN QUANTITY (ALSO REPORTED AS POTENTIALLY TWELVE) OF LOW RECIRCULATION VOLUME APD SET WITH CASSETTES WERE DAMAGED. THERE WAS A "SLICE" OBSERVED IN THE TUBING DURING SET UP. THERE WAS NO DAMAGED NOTED TO THE OVERPOUCH OF THE CASSETTE AND NO OTHER DAMAGE WAS VISIBLE UPON INSPECTION OF THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620546 ↗
• MalfunctionOct 17, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A SMALL PINHOLE IN THE PATIENT LINE OF AN UNSPECIFIED QUANTITY OF LOW RECIRCULATION VOLUME APD SET WITH CASSETTES WHICH RESULTED IN LEAK. THIS WAS OBSERVED DURING PRIMING OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15617545 ↗
• MalfunctionOct 17, 2022Scratched Material; Scratched Material

  IT REPORTED AN UNSPECIFIED QUANTITY OF HOMECHOICE LOW RECIRCULATION VOLUME APD SETS WITH CASSETTE WERE DAMAGED; FURTHER DESCRIBED AS ¿HAVE SCRATCHES AND ARE COMPROMISED¿. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616031 ↗
• MalfunctionJun 1, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HOMECHOICE CASSETTE LEAKED. THE NURSE FURTHER REPORTED, ¿THE WHITE CONNECTOR OF THE PATIENT LINE BECAME SEPARATED DURING THERAPY. DURING DWELL, THE PATIENT¿S MOTHER OBSERVED THAT THE WHITE CONNECTOR WAS SEPARATED FROM THE PATIENT LINE TUBING AND WAS STILL CONNECTED TO THE TRANSFER SET¿. THE PATIENT¿S MOTHER NOTICED ¿LIQUID ON THE BED¿. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565025 ↗