LOW RECIRCULATION VOLUME APD SETRecalls & reported problems across all models

We found 2 models of LOW RECIRCULATION VOLUME APD SET by Baxter International Inc. in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2018 and Jul 30, 2026 — classified as 69 malfunctions.

The most frequently reported specific device problem is “Disconnection” (18 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LOW RECIRCULATION VOLUME APD SET problems

LOW RECIRCULATION VOLUME APD SET models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LOW RECIRCULATION VOLUME APD SET N5C8305C

  SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
  60 reports
• LOW RECIRCULATION VOLUME APD SET 5C8302C

  SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
  9 reports

Recent LOW RECIRCULATION VOLUME APD SET adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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