HOMECHOICE APD SET 5C4469C (UDI 07332414208479)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07332414208479), received between Nov 5, 2025 and Sep 24, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Component Missing

  It was reported that the blue protective cap (pull ring) on the patient-end connector (patient line) of a HomeChoice Cassette was ¿missing completely¿. 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 50888491 ↗
• MalfunctionSep 23, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875612 ↗
• MalfunctionSep 17, 2026Component Missing

  It was reported that the blue pull ring cap on the patient line of the HomeChoice Cassette was missing. 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 50803800 ↗
• MalfunctionAug 31, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521144 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE TUBING OF FOUR (4) HOMECHOICE CASSETTES. 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 25330798 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE FEMALE CONNECTOR OF SIX (6) UNITS OF THE MINICAP TRANSFER SET. THIS OCCURRED BEFORE 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 25113510 ↗
• MalfunctionApr 20, 2026Scratched Material

  IT WAS REPORTED THAT THERE WERE SCRATCHES ON THE PIPE (TUBING) WALL OF FIFTEEN (15) HOMECHOICE CASSETTES. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925490 ↗
• MalfunctionMar 11, 2026Disconnection

  IT WAS REPORTED THAT THE PROTECTIVE CAP (PULL RING CAP) ON THE PATIENT LINE OF A HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THE ISSUE WAS DESCRIBED AS ¿ THE HAT ON THE PIPE 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 24568524 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) HOMECHOICE CASSETTE LEAKED FROM AN UNKNOWN LOCATION. THIS OCCURRED DURING USE OF THE DEVICES 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 24461510 ↗
• MalfunctionFeb 13, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A FOREIGN OBJECT INSIDE THE TUBING OF THE HOMECHOICE CASSETTE. 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 24332025 ↗
• MalfunctionJan 28, 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 24201061 ↗
• MalfunctionJan 28, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THREE (3) HOMECHOICE CASSETTES WAS LOOSE AND FELL OFF. THIS WAS IDENTIFIED BEFORE OPENING THE PACKAGING IN PREPARATION 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 24200880 ↗
• MalfunctionJan 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING SETUP AND PREPARATION 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 24190405 ↗
• MalfunctionDec 4, 2025Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PULL RING CAP OF A HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS WAS OBSERVED 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 23720813 ↗
• MalfunctionNov 25, 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 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 23647425 ↗
• MalfunctionNov 24, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE WAS DAMAGED WHICH RESULTED IN A LEAK. FLUID WAS LEAKING FROM UNDERNEATH THE CYCLER. THIS OCCURRED DURING SETUP AND PREPARATION 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 23638611 ↗
• MalfunctionNov 24, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP OF A HOMECHOICE CASSETTE WAS LOOSE AND FELL OFF. THIS WAS OBSERVED 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 23635314 ↗
• MalfunctionNov 13, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT CONNECTOR OF TWO (2) HOMECHOICES CASSETTES WERE ¿ASKEW¿ WHICH RESULTED IN A LEAK. 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. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544647 ↗
• MalfunctionNov 5, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER (PM) INSIDE THE TUBING OF A HOMECHOICE AUTOMATED PD SET WITH CASSETTE. THIS WAS OBSERVED WHILE PRIMING THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477641 ↗

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