Zenysis Dual Lumen Acute Dialysis Catheter A853150Recalls & reported problems
Bard Access Systems, Inc. · Zenysis DL, 15cm ST Kit · Class 2
Data updated Oct 18, 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 00801741109744), received between Aug 26, 2016 and Aug 26, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Collapse” (2 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
Device problems
- Collapse2
- Kinked2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2016Collapse; Kinked
ON (B)(6) 2016 - PER SALES REPRESENTATIVE, FACILITY REPORTED THAT A ZENYSIS CATHETER BECAME KINKED AND COLLAPSED AT THE "NECK" OF THE CATHETER DURING PLASMAPHERESIS. IT WAS STATED THAT THE CATHETER NEEDED TO BE REPLACED WITHIN 24 HOURS OF PLACEMENT. THIS EVENT ADDRESSES CATHETER TWO.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5906375 ↗MalfunctionAug 26, 2016Collapse; Kinked
ON (B)(6) 2016- PER SALES REPRESENTATIVE, FACILITY REPORTED THAT A ZENYSIS CATHETER BECAME KINKED AND COLLAPSED AT THE "NECK" OF THE CATHETER DURING PLASMAPHERESIS. IT WAS STATED THAT THE CATHETER NEEDED TO BE REPLACED WITHIN 24 HOURS OF PLACEMENT. THIS EVENT ADDRESSES CATHETER ONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5906372 ↗
Other CATHETER, HEMODIALYSIS, NON-IMPLANTED devices
- MAHURKAR 8888135191Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall175 reports
- MAHURKAR 8888135241Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall1 death100 reports
- ARROW IPN036723Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls2 reports
- ARROW IPN036412Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- DuoGlide catheter 5625240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- ARROW IPN036428Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN036419Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN927343Teleflex Incorporated · Catheter, hemodialysis, non-implanted2 recalls0 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.
How reports and recalls are matched · Editorial policy · Report an error on this page