CYCLER DRAINAGE BAG 5C4145NSRecalls & reported problems
Baxter Healthcare Corporation · The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Vantive Automated Peritoneal Dialysis (APD) Cycler Tubing Sets. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07332414207939), received between Jun 23, 2025 and Jul 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CLIP OF FOUR (4) 15L CYCLER DRAINAGE BAGS (NON-STERILE) WOULD OPEN WHICH RESULTED IN A LEAK. THIS OCCURRED WHEN THE DEVICES WERE DISCONNECTED, AFTER 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 22520380 ↗MalfunctionJun 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE UPPER PART OF TWO (2)15L CYCLER DRAINAGE BAGS WERE CUT OFF. 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 22307155 ↗
Other SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE devices
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- MINICAP WITH POVIDONE-IODINE SOLUTION 5C4466PBaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall4 deaths347 reports
- MINICAP EXTENDED LIFE PD TRNS 5C4482ABaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE193 reports
- UltraSet CAPD Disposable Disconnect Y-Set L5C4366Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE100 reports
- stay.safe® 050-95012Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall48 reports
- stay.safe® 050-95004Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall43 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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