HomeChoice APD System 5C4471Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00085412007021), received between Jul 2, 2024 and Jun 26, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Unintended Electrical Shock” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED FEELING FULL; DIFFICULTY BREATHING AND DRAIN PAIN DURING DRAIN 4 OF 5. THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF THE EVENTS. ACCORDING TO THE REPORTER, A MANUAL DRAIN WAS PERFORMED. IT WAS REPORTED THAT PD THERAPY WAS DISCONTINUED WITH A TOTAL UF OF 913 ML. RENAL THERAPY SERVICES INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE REPORTER STATED THE SYMPTOMS WERE RESOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea; Pain

  MAUDE report 25642131 ↗
• MalfunctionJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CAREGIVER THAT THE PATIENT WAS "FEELING UNWELL, VERY SWOLLEN, AND HAVING DIFFICULTY BREATHING" WHEN USING THE HONECHOICE CYCLER FOR THERAPY. IT WAS REPORTED THAT AFTER MANUAL DRAIN, THE PATIENT FELT BETTER AND HAD NO DIFFICULTY BREATHING. THE CAREGIVER ENDED THE THERAPY EARLY. IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO THE CLINIC AND PRESENTED WITH DYSPNEA, ABDOMINAL DISTENSION, AND "HYPERTENSIVE PEAK." IT WAS REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED. THERE WAS NO MEDICAL INTERVENTIONS REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea; High Blood Pressure/ Hypertension

  MAUDE report 25552639 ↗
• MalfunctionMay 8, 2026Unintended Electrical Shock

  IT WAS REPORTED THAT THE OPERATOR FELT AN ELECTRIC SHOCK IN THEIR HAND WHEN THE HOMECHOICE DEVICE WAS TURNED ON OR OFF USING THE SWITCH ON THE BACK. THIS WAS DESCRIBED AS A ¿FELT A PULL¿. THIS OCCURRED DURING AN UNSPECIFIED STEP OF AUTOMATED PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. 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 25127535 ↗
• MalfunctionMay 7, 2026Unintended Electrical Shock

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ELECTRIC SHOCK DURING USE WITH A HOMECHOICE AUTOMATED PD SYSTEM FOR PERITONEAL DIALYSIS THERAPY. THE SHOCK WAS FELT WHEN THE PATIENT WAS STANDING TOUCHING THE LEVER OF THE CYCLER. THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. 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 25116557 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED DIFFICULTY BREATHING AND FEELING FULL DURING FILL 1 OF 6. THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF THE EVENTS. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS REPORTED AS "FEELING BETTER BUT STILL FELT FULL". NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 25021628 ↗
• MalfunctionApr 15, 2026Unintended Electrical Shock

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ELECTRIC SHOCK BELOW THE ABDOMEN FROM A HOMECHOICE DEVICE. THIS OCCURRED DURING FILLING OF AUTOMATED 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 24885598 ↗
• MalfunctionJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PASSED AWAY WHILE CONNECTED TO A HOMECHOICE MACHINE. THE CAUSE OF DEATH WAS NOT REPORTED. THERE WAS NO REPORT OF HOSPITALIZATION PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT PD THERAPY WAS ONGOING PRIOR TO DEATH AND AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24043760 ↗
• MalfunctionJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT PASSED AWAY WHILE USING A HOMECHOICE DEVICE. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT PD THERAPY WAS ONGOING PRIOR TO DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23982907 ↗
• MalfunctionDec 11, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT A HOMECHOICE DEVICE PRESENTED AN ELECTRIC SHOCK. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP 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 23782624 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED BLOATEDNESS AND "HAVING ISSUES TO BREATHE" DURING AN UNKNOWN PROCESS STEP. THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF THE EVENT. THE PATIENT WAS IN THE HOSPITAL FOR AN UNSPECIFIED CONDITION. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 22309991 ↗
• MalfunctionApr 23, 2025Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT A PATIENT EXPERIENCED ELECTRIC SHOCK WITH A HOMECHOICE CYCLER SPECIFIED AS ¿FELT TOUCHES WHEN PRESSED A BUTTON." THIS OCCURRED DURING USE OF THE DEVICE 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 21893058 ↗
• MalfunctionMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT PASSED AWAY DURING AN UNKNOWN PROCESS STEP OF PD THERAPY USING A HOMECHOICE DEVICE. IT WAS REPORTED THE PATIENT WAS NOT CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. RENAL THERAPY SERVICES INITIATED A SWAP OF THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21594001 ↗
• MalfunctionJul 2, 2024Fire; Fire

  IT WAS REPORTED THAT THE HOMECHOICE DEVICE WAS BURNED. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP 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 19657593 ↗