X-1 APD Cycler 1B1207Recalls & reported problems
Byonyks Private Limited · The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis. · Class 2
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 08964004471001), received between Jun 23, 2026 and Jun 23, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Conduct” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Conduct1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 23, 2026Failure to Conduct
PERITONEAL DIALYSIS PATIENT REPORTED TO TECHNICAL SUPPORT THAT DURING THE BAG HEATING PROCESS, THE CYCLER DIDN'T ADVANCE TO THE NEXT STEP. THE PATIENT COMPLETED TREATMENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WITH NO COMPLICATIONS. THE DEVICE WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25592952 ↗
Other System, Peritoneal, Automatic Delivery devices
- Liberty® Select Cycler 180343Fresenius Medical Care Holdings, Inc. · System, peritoneal, automatic delivery1 recall545 deaths15,896 reports
- Liberty® 050-87216Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY16 deaths9,148 reports
- Liberty® 050-87212Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY12 deaths2,169 reports
- Liberty® 180111Fresenius Usa, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY126 deaths1,716 reports
- Amia Automated PD Set with Cassette 5C5479Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 recall976 reports
- INTERGRATED APD SET L5C4531Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY811 reports
- Liberty 050-87216AFresenius Medical Care Renal Therapies Group, LLC · System, Peritoneal, Automatic Delivery1 death678 reports
- NA R5C4479Baxter Healthcare SA · System, peritoneal, automatic delivery373 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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