HOMECHOICE APD SET 5C4469C (UDI 00085412087375)Recalls & reported problems

Summary

The FDA's MAUDE database contains 252 adverse event reports that list this exact device (DI 00085412087375), received between Jun 26, 2018 and May 5, 2026 — classified as 4 injuries, 248 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (101 reports).

4 other recalls cover devices cleared under the same FDA submission (K923065); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 252 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Disconnection

  IT WAS REPORTED THAT THE PIPE COVER (PULL RING CAP) ON THE TUBING OF THE HOMECHOICE CASSETTE FELL OFF. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084141 ↗
• MalfunctionApr 22, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THREE (3) HOMECHOICE CASSETTES WERE MISSING. THIS WAS IDENTIFIED AFTER PRIMING 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 24951913 ↗
• MalfunctionMar 31, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS MISSING. THIS WAS IDENTIFIED DURING SETUP 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 24742392 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE HOMECHOICE CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING PRIME 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 24734113 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT CONNECTORS OF THE HOMECHOICE CASSETTE WERE BROKEN. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698109 ↗
• MalfunctionMar 17, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS MISSING. THIS WAS IDENTIFIED DURING SETUP 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 24617067 ↗
• MalfunctionMar 4, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS WAS IDENTIFIED BEFORE 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 24513719 ↗
• MalfunctionMar 4, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS WAS IDENTIFIED BEFORE 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 24513400 ↗
• MalfunctionMar 2, 2026Crack

  IT WAS REPORTED THAT THE CONNECTOR OF THE HOMECHOICE CASSETTE WAS CRACKED. THIS WAS IDENTIFIED 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 24486122 ↗
• MalfunctionFeb 27, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF A HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS WAS IDENTIFIED BEFORE 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 24472124 ↗
• MalfunctionFeb 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE HOMECHOICE CASSETTE LEAKED FROM AN UNKNOWN LOCATION. 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 24445627 ↗
• MalfunctionFeb 19, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF TWO (2) HOMECHOICE CASSETTES WERE LOOSE AND FELL OFF. THIS OCCURRED DURING SETUP 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 24388920 ↗
• MalfunctionFeb 9, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS OCCURRED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293065 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258391 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS LEAK BETWEEN THE TUBING AND CASSETTE OF A HOMECHOICE CASSETTE. THE TUBE FELL OFF FROM THE HOMECHOICE CASSETTE. THIS OCCURRED DURING PRIME 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 24258269 ↗
• MalfunctionFeb 2, 2026Component Missing

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE SET WAS MISSING THE CAP FROM THE PATIENT LINE (NOT INSIDE THE POUCH). THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE FOR AUTOMATED PERITONEAL DIALYSIS (APD) 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 24235190 ↗
• MalfunctionJan 26, 2026Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF A HOMECHOICE CASSETTE WAS FOUND TO BE LOOSE AND IT FELL OFF. THIS OCCURRED PRIOR TO 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 24180397 ↗
• MalfunctionJan 21, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF A HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS OCCURRED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136836 ↗
• MalfunctionJan 20, 2026Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS OBSERVED IN A HOMECHOICE CASSETTE. THIS WAS DESCRIBED AS ¿FOUND AN OBVIOUS SCRATCH IN THE MIDDLE OF THE PIPING AT THE PATIENT END: UNEVEN TO THE TOUCH¿. THIS WAS OBSERVED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121774 ↗
• MalfunctionJan 14, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS OCCURRED DURING PRIME OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069437 ↗
• MalfunctionDec 31, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT CONNECTOR ON THE HOMECHOICE CASSETTE WAS DAMAGED WHICH RESULTED IN LEAK. THIS OCCURRED DURING SETUP 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 23934329 ↗
• MalfunctionDec 30, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS OCCURRED AFTER OPENING THE PACKAGE, BEFORE 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 23924834 ↗
• MalfunctionDec 30, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS OCCURRED BEFORE OPENING THE PACKAGE. 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 23924707 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT CONNECTOR OF THE HOMECHOICE CASSETTE WAS BROKEN. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907209 ↗
• MalfunctionDec 29, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS OCCURRED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906070 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923065. One submission often covers many models, so check the product and lot details in each record.

• Z-2132-2012 · Jul 6, 2012 · Terminated
  Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufa
• Z-0946-2008 · Nov 20, 2007 · Terminated
  Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Manufactured for Baxter Healthcare Corporation, D
• Z-1018-05 · Jun 21, 2005 · Terminated
  HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C447
• Z-1012-04 · May 24, 2004 · Terminated
  HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C447