UltraSet CAPD Disposable Disconnect Y-Set 5C4366PRecalls & reported problems
Baxter International Inc. · The UltraSet products are single use devices that are intended for the drainage and infusion of peritoneal dialysis solution. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This UltraSet CAPD Disposable Disconnect Y-Set is a single-use Baxter set used to drain and fill peritoneal dialysis solution. The 70 reports mostly describe leaking or moisture at the tubing, seams or bag, punctures or holes in the material, and connections that did not seal properly; none mention a death or an injury, and many were found before or during use with no patient harm described. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 70
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00085412030579), received between May 14, 2018 and Apr 29, 2026 — classified as 70 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (38 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak38
- Material Puncture/Hole17
- Break5
- Disconnection4
- Device Contamination with Chemical or Other Material3
- Incomplete or Inadequate Connection3
- Loose or Intermittent Connection3
- Connection Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient21
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Crack; Material Puncture/Hole
IT WAS REPORTED THAT AN ISSUE DESCRIBED AS A FISSURE OR PERFORATION WAS FOUND IN ONE (1) UNIT OF AN ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET. THIS WAS IDENTIFIED PRIOR TO 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 25034071 ↗MalfunctionApr 1, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAK FROM THE DRAIN BAG TUBING OF AN ULTRASET 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 24757305 ↗MalfunctionFeb 10, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE DRAIN BAG OF AN ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET WAS STUCK TO THE OUTER POUCH AND CAUSED A TEAR WHICH RESULTED IN A LEAK. 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 24308220 ↗MalfunctionJul 31, 2025Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE WITH A 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 22674239 ↗MalfunctionJul 24, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE WITH THE CAPD DISCONNECT Y SET. THE PATIENT LINE DID NOT CREATE A PROPER SEAL CONNECTED TO THE TRANSFER SET. 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 22589513 ↗MalfunctionJun 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CAPD DISCONNECT Y SET LEAKED. THE EVENT 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 22211253 ↗MalfunctionMay 2, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) CAPD DISCONNECT Y-SETS LEAKED; DESCRIBED AS ¿THERE WAS A LEAK OR EXCESSIVE MOISTURE¿. THIS WAS IDENTIFIED PRIOR TO USE 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 21954772 ↗MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) ULTRASET CAPD DISPOSABLE DISCONNECT Y-SETS LEAKED FROM THE SEAM. FLUID WAS ON FLOOR. 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 21885247 ↗MalfunctionMar 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SIX (6) ULTRASET CAPD DISPOSABLE DISCONNECT Y-SETS LEAKED. SOME SETS LEAKED FROM THE SEAM AND SOME FROM THE CONNECTION. 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 21585396 ↗MalfunctionDec 11, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET LEAKED AT THE SEAM OF THE DRAIN BAG. 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 20904159 ↗MalfunctionNov 7, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT A CAPD DISPOSABLE DISCONNECT Y-SET WAS DAMAGED; FURTHER DESCRIBED AS ¿A HOLE WHERE IT JOINED THE TUBE¿. 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 20633953 ↗MalfunctionAug 8, 2024Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture
IT WAS REPORTED THAT THE SOLUTION CONTAINING BAG OF A CAPD DISCONNECT Y SET "BURST" WHICH RESULTED IN A LEAK. THIS OCCURRED AFTER 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 19945239 ↗MalfunctionJun 25, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE DRAIN BAG JOINT OF A CAPD DISPOSABLE DISCONNECT Y-SET COULD NOT TIGHTLY INTEGRATE THE PATIENT CONNECTOR. IT WAS FURTHER STATED THAT THE CLASP WAS CLOSED WITHOUT OPENING, BUT IT BOUNCED OPEN. THIS OCCURRED DURING 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 19610752 ↗MalfunctionJun 12, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT THE DRAIN BAG OF A CAPD DISPOSABLE DISCONNECT Y-SET WAS BROKEN WHICH RESULTED IN A LEAK. THIS OCCURRED AFTER 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 19519885 ↗MalfunctionMay 2, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CAPD DISCONNECT Y SET LEAKED; FURTHER DESCRIBED AS ¿THE FLOOR WAS WET DUE TO LEAKAGE¿. 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 19234397 ↗MalfunctionApr 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A CAPD DISCONNECT Y SET LEAKED FROM THE BAG. THIS OCCURRED DURING SET UP 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 19051527 ↗MalfunctionMar 18, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THERE WAS A HOLE IN A CAPD DISPOSABLE DISCONNECT Y-SET. THIS WAS DESCRIBED AS ¿AS THE AMOUNT OF DOUBLE VOLUME INCREASES, A HOLE IS CREATED AS THE BAG INCREASES¿. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS THERAPY (CAPD). 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 18924957 ↗MalfunctionNov 27, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE DRAIN BAG OF AN ULTRA SET DISPOSABLE DISCONNECT Y-SET HAD A HOLE; FURTHER DESCRIBED AS "A HOLE IN THE SEAM NEAR THE NECK GOING TO THE UPWARDS TUBE". THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED TO THE DEVICE. 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 18210312 ↗MalfunctionNov 2, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF ULTRA SET DISPOSABLE DISCONNECT Y-SETS LEAKED FROM THE DRAIN BAGS. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF 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 18056216 ↗MalfunctionSep 14, 2023Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN A MINICAP TRANSFER SET AND AN ULTRA SET DISPOSABLE DISCONNECT Y-SET. 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 17749904 ↗MalfunctionSep 14, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN AN ULTRA SET DISPOSABLE DISCONNECT Y-SET AND THE TRANSFER SET. THIS OCCURRED 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 17749084 ↗MalfunctionSep 12, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THREE (3) ULTRA SET DISPOSABLE DISCONNECT Y-SETS HAD A CONNECTION ISSUE; FURTHER DESCRIBED AS ¿THE CONNECTION OF THE PATIENT END OF THE EMPTY BAG IS NOT TIGHT." 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 17728037 ↗MalfunctionJul 28, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THERE WAS A HOLE IN THE BAG OF AN ULTRA SET DISPOSABLE DISCONNECT Y-SET WHICH RESULTED IN A LEAK. THIS WAS OBSERVED DURING 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 17418125 ↗MalfunctionJul 10, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT TWO (2) ULTRA SET DISPOSABLE DISCONNECT Y-SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING PRIMING OF 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 17289572 ↗MalfunctionJun 27, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE DRAIN BAGS OF TWO (2) ULTRA SET DISPOSABLE DISCONNECT Y-SETS LEAKED. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. ONE (1) BAG WAS LEFT HANGING; THE CLAMPS WERE CLOSED AND THE BAG WAS FOUND EMPTY ON THE FLOOR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17209960 ↗
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- stay.safe® 050-95012Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall48 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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