stay.safe® 026-20030Recalls & reported problems
Fresenius Medical Care Holdings, Inc. · stay.safe® Drain Set · Class 2
All models of stay.safe (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840861100583), received between Nov 1, 2017 and Nov 1, 2017 — classified as 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2017Fluid/Blood Leak; Fluid/Blood Leak
A PERITONEAL DIALYSIS (PD) PATIENT'S REGISTERED NURSE (RN) REPORTED THE PATIENT REPORTED THE BOTTOM SEAM CORNER OF THE BAG WAS NOT COMPLETELY SEALED AND LEAKED DURING TREATMENT. PER PDRN NO FLUID CAME INTO CONTACT WITH THE CYCLER. PER PDRN THE PATIENT WAS ABLE TO RE-SETUP WITH SUPPLIES TO COMPLETE TREATMENT WHEN THE ISSUE OCCURRED, THUS NO TREATMENT WAS MISSED. PER PDRN THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION OR ADDITIONAL TREATMENT AS A RESULT OF THE REPORTED LEAK, AND NO ADVERSE EVENT OCCURRED. PER PDRN THE PATIENT CONTINUES TO USE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITH THE CYCLER WITHOUT FURTHER ISSUE. PER PDRN THE SAMPLE WAS DISCARDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6994493 ↗
Other SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE devices
- MiniCap 5C4482Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE3 recalls5 deaths2,961 reports
- MiniCap 5C4483Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE4 recalls433 reports
- Safe-Lock® 050-95018Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE2 recalls509 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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