LOW RECIRCULATION VOLUME APD SET 5C8302CRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412087405), received between Nov 20, 2018 and Apr 1, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 reports).

9 other recalls cover devices cleared under the same FDA submission (K012988); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE LOW RECIRCULATION VOLUME APD SET AND MINICAP TRANSFER SET. THE PATIENT WOKE UP DISCONNECTED. THIS WAS FURTHER DESCRIBED AS ¿THE CASSETTE DID NOT 'LOCK' AND KEPT ROTATING, AS IF THERE WAS A PROBLEM WITH THE THREAD, APPEARING WORN OUT¿. ADHESIVE TAPE WAS APPLIED TO PREVENT IT FROM COMING LOOSE. 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; HOWEVER, THE PATIENT WAS GIVEN ANTIBIOTICS PROPHYLACTICALLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739633 ↗
• MalfunctionApr 1, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE LOW RECIRCULATION VOLUME APD SET AND MINICAP TRANSFER SET. THE PATIENT WOKE UP DISCONNECTED. THIS WAS FURTHER DESCRIBED AS ¿THE CASSETTE DID NOT 'LOCK' AND KEPT ROTATING, AS IF THERE WAS A PROBLEM WITH THE THREAD, APPEARING WORN OUT¿. ADHESIVE TAPE WAS APPLIED TO PREVENT IT FROM COMING LOOSE. 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, HOWEVER, THE PATIENT WAS GIVEN ANTIBIOTICS PROPHYLACTICALLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739048 ↗
• MalfunctionOct 15, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE CAP WAS DISCONNECTED FROM THE PATIENT LINE OF A HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE; THIS WAS DESCRIBED AS ¿WHEN THE PACKAGE WAS OPENED, THE CAP OF THE TUBE WAS NOT CONNECTED¿. 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 20452300 ↗
• MalfunctionSep 5, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE PATIENT LINE CAP (PULL RING) OF SIX (6) HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTES HAD COME LOOSE WHILE IN THE PACKAGING. THIS WAS OBSERVED BEFORE USE OF THE DEVICES 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 17682905 ↗
• MalfunctionApr 14, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE PROTECTIVE CAP OF THE PATIENT LINE OF THE HOMECHOICE CASSETTE WAS LOOSE INSIDE THE INDIVIDUAL PACKAGING. 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 16742101 ↗
• MalfunctionFeb 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE LEAK WAS DESCRIBED AS, ¿NOTICED LEAKAGE OF PERITONEAL DIALYSIS SOLUTION THROUGH THE CASSETTE¿. THE LEAK WAS OBSERVED WHILE PRIMING FOR PERITONEAL DIALYSIS (PD) THERAPY PRIOR TO PATIENT CONNECTION. 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 16285903 ↗
• MalfunctionApr 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE HAD PARTICULATE MATTER (PM). THE PM WAS FURTHER DESCRIBED AS "A BROWN SPOT INSIDE THE LINE UNDER THE PLUG¿. THIS WAS OBSERVED AFTER PRIMING 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 14052707 ↗
• MalfunctionOct 29, 2019Disconnection; Fluid/Blood Leak; Protective Measures Problem; Disconnection; 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 USE OF THE HOMECHOICE CASSETTE DURING PERITONEAL DIALYSIS THERAPY. DURING THE TROUBLESHOOTING, IT WAS REPORTED THAT THE DRAINAGE LINE SEPARATED FROM THE HOMECHOICE CASSETTE CAUSING A LEAK WHICH LED TO THE ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252793 ↗
• MalfunctionNov 20, 2018Fluid/Blood Leak; Incomplete or Inadequate Connection; Fluid/Blood Leak; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED BECAUSE THE CONNECTION BETWEEN THE UNSPECIFIED SET AND CASSETTE DID NOT LOCK. THE CUSTOMER STARTED THE TREATMENT AND DURING THE INFUSION, THE CONNECTION OPENED. THIS OCCURRED WHILE IN USE ON A PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092195 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012988. One submission often covers many models, so check the product and lot details in each record.

• Z-0947-2008 · Nov 20, 2007 · Terminated
  HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R, Manufactured for Baxter Healthcare Corporation, D
• Z-0139-06 · Sep 12, 2005 · Terminated
  Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., M
• Z-1019-05 · Jun 21, 2005 · Terminated
  HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R
• Z-0397-05 · Dec 23, 2004 · Terminated
  HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R
• Z-0189-05 · Nov 1, 2004 · Terminated
  HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C83
• Z-0188-05 · Nov 1, 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
• Z-1013-04 · May 24, 2004 · Terminated
  HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C831
• Z-0565-03 · Dec 23, 2002 · Terminated
  HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R
• Z-0564-03 · Dec 23, 2002 · 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