UltraSet CAPD Disposable Disconnect Y-Set L5C4366Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00085412090085), received between Mar 6, 2018 and Aug 25, 2026 — classified as 3 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (55 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. 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 25 most recent of 100 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50441795 ↗
• MalfunctionJun 23, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE BAG OF AN ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SET WHICH RESULTED IN A LEAK. 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 25598032 ↗
• MalfunctionJun 9, 2026Fitting Problem

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE WITH AN UNSPECIFIED QUANTITY OF CAPD DISCONNECT Y-SETS; DESCRIBED AS ¿THE MANUAL DRAIN BAGS WERE NOT FITTING PROPERLY¿. THIS OCCURRED DURING USE OF THE DEVICES FOR AUTOMATED 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 25445420 ↗
• InjuryJan 12, 2026Fluid/Blood Leak

  A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS USING CAPD (CONTINUOUS AMBULATORY PD) STERILE FLUID PATH Y SET. IT WAS REPORTED THAT THE "SAMPLE PORT WITH THE BLUE PIECE WAS LEAKING WHEN DOING THE EXCHANGE", FURTHER REPORTED AS "WHILE FLUSHING THE LINE BEFORE IT STARTS IT LEAKS". THE PATIENT RECEIVED UNSPECIFIED TREATMENT FOR THE EVENT. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. IT WAS REPORTED THAT PD THERAPY WAS PUT ON HOLD. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 24044562 ↗
• MalfunctionJan 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A CAPD DISCONNECT Y-SET LEAKED ON THE CARPET FROM THE SEAM OF THE BAG. THIS OCCURRED DURING USE OF THE DEVICE FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) 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 23993932 ↗
• MalfunctionOct 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DRAIN BAG OF AN ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SET LEAKED FLUID ONTO THE FLOOR. 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 23311884 ↗
• MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE BAG AND TUBING OF AN ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SET. 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 23038890 ↗
• MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE BAG AND TUBING OF AN ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SET. 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 23038713 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY (AT LEAST A FEW) OF ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SETS LEAKED. THIS OCCURRED DURING SETUP/PREPARATION 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 22337643 ↗
• MalfunctionMay 7, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THIRTY (30) UNITS OF THE CAPD DISCONNECT Y-SET AND THE MINICAP TRANSFER SET. THE Y-SETS WERE NOT PROPERLY CONNECTING TO THE TRANSFER SET. THIS OCCURRED "WHILE ATTEMPTING TO CONNECT THE BAG TO THE PATIENT'S TRANSFER SET" FOR USE IN 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 21977884 ↗
• MalfunctionApr 24, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE WITH A CAPD DISCONNECT Y-SET; DESCRIBED AS ¿UNABLE TO HOOK UP THE Y SET TO DRAIN- IT WOULD NOT FIT ON¿ THE PATIENT¿S CATHETER. THIS OCCURRED DURING SETUP/PREPARATION 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 21904805 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT THE WATER BAG OF TWO (2) CAPD DISPOSABLE DISCONNECT Y-SETS WERE BROKEN. THIS WAS OBSERVED 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 20773896 ↗
• MalfunctionSep 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BAG OF A CAPD DISCONNECT Y SET LEAKED. 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 20295413 ↗
• MalfunctionSep 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BAG OF A CAPD DISCONNECT Y SET LEAKED. THIS OCCURRED DURING DRAINING 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 20294218 ↗
• MalfunctionSep 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CAPD DISCONNECT Y SET LEAKED. THIS OCCURRED DURING DRAIN 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 20157389 ↗
• MalfunctionAug 28, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT TWELVE (12) CAPD DISPOSABLE DISCONNECT Y-SETS "ARRIVED OPENED." THE BAGS WERE NOT SEALED PROPERLY. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICES 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 20091214 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A CAPD DISCONNECT Y SET LEAKED; FURTHER DESCRIBED AS "LEAKING UPON INITIAL DRAIN AT THE TOP OF THE DRAIN BAG WHERE THE TUBING CONNECTS TO THE BAG" AND "FLUID ON THE FLOOR". THIS WAS OBSERVED DURING THE INITIAL DRAIN STEP OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY; THE DEVICE WAS CLAMPED AND DISCONNECTED. 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 20076916 ↗
• MalfunctionAug 18, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT AN ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SET CAME APART AT THE Y-SET. THIS WAS NOTICED 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 19999316 ↗
• MalfunctionAug 15, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE ULTRA SET CAPD DISPOSABLE DISCONNECT Y-SET CAME APART AT THE YSET. 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 19992090 ↗
• MalfunctionAug 14, 2024Break; Incomplete or Inadequate Connection; Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE "THREADS" OF A CAPD DISCONNECT Y SET T WERE STRIPPED AND WOULD NOT LOCK IN PLACE OR TIGHTEN. THIS OCCURRED DURING TRAINING FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19985869 ↗
• MalfunctionJul 5, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT A CAPD DISCONNECT Y SET HAD A CONNECTION ISSUE; FURTHER DESCRIBED AS ¿THE THREADS SEEMED TO SLIP AROUND THE END OF THE TRANSFER SET AND NEVER MAKE A TIGHT CONNECTION." UPON INSPECTION OF THE THREADS OF THE Y SET IT APPEARED THAT THE THREADS WERE NOT CORRECT. THIS OCCURRED DURING SET-UP AND PREPARATION 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 19683287 ↗
• MalfunctionJun 27, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED A PERITONEAL DIALYSIS PATIENT OBSERVED HOLES IN 23 ULTRASET CAPD DISPOSABLE DISCONNECT Y-SETS PRIORI TO USE. THE CAUSE OF THE HOLES WAS UNKNOWN. THE CAREGIVER REPORTED THEY DID NOT NOTICE ANY DAMAGE WITH THE OVERPOUCH PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629338 ↗
• InjuryJun 27, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED A PERITONEAL DIALYSIS PATIENT EXPERIENCED A LEAK FROM AN ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET. IT WAS FURTHER REPORTED THE PATIENT NOTICED A HOLE ON THE SET. THE CAUSE OF THE HOLE WAS UNKNOWN. SUBSEQUENTLY, THE PATIENT EXPERIENCED PERITONITIS. HOSPITALIZATION, TREATMENT, PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Peritonitis

  MAUDE report 19629209 ↗
• MalfunctionJun 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF CAPD DISCONNECT Y SETS WERE DAMAGED; FURTHER DESCRIBED AS "COMING APART AT THE Y-SET". THIS WAS OBSERVED 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 19581412 ↗
• MalfunctionJun 6, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A CAPD DISCONNECT Y SET HAD A PINHOLE IN THE BOTTOM CORNER OF THE DRAIN BAG. THIS WAS OBSERVED 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 19476858 ↗