Zenysis Dual Lumen Acute Dialysis Catheter A863150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741109775), received between Aug 26, 2016 and Aug 26, 2016 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Kinked” (4 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2016Kinked; Cut In Material; Split

  ON (B)(6) 2016- PER SALES REPRESENTATIVE, THE FACILITY REPORTED AN ISSUE WITH A ZENYSIS DUAL LUMEN CATHETER THAT WAS INSERTED IN A PATIENT. ON 08/17/2016 - THE PICTURE RECEIVED APPEARS TO SHOW A SPLIT IN THE CATHETER NEAR THE INSERTION SITE. ON 08/17/2016 - PER THE SALES REPRESENTATIVE: "THE CATHETER IS COMPLETELY KINKED OVER AT THE BASE OF THE HUB WHERE THE CATHETER SHAFT BEGINS. YOU CAN SEE THE SEPTUM BETWEEN THE TWO LUMENS WHERE THERE IS PRESSURE ON THE CATHETER." ON 08/18/2016- ADDITIONAL INFORMATION FROM SALES REPRESENTATIVE STATED, "CATHETER BENDING/KINKING JUST BELOW HUB WHERE SECURED BY SUTURES IMPAIRING THE CATHETER'S ABILITY TO FLOW. THE SUTURES HAD TO BE CUT AND CATHETER STRAIGHTENED OUT TO USE. NO PATIENT INJURY REPORTED. THIS REPORT IS REGARDING PATIENT 4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5906852 ↗
• MalfunctionAug 26, 2016Kinked; Split

  ON (B)(6) 2016- PER SALES REPRESENTATIVE, THE FACILITY REPORTED AN ISSUE WITH A ZENYSIS DUAL LUMEN CATHETER THAT WAS INSERTED IN A PATIENT. ON (B)(6) 2016 - THE PICTURE RECEIVED APPEARS TO SHOW A SPLIT IN THE CATHETER NEAR THE INSERTION SITE. ON (B)(6) 2016 - PER THE SALES REPRESENTATIVE: "THE CATHETER IS COMPLETELY KINKED OVER AT THE BASE OF THE HUB WHERE THE CATHETER SHAFT BEGINS. YOU CAN SEE THE SEPTUM BETWEEN THE TWO LUMENS WHERE THERE IS PRESSURE ON THE CATHETER." ON (B)(6) 2016- ADDITIONAL INFORMATION FROM SALES REPRESENTATIVE STATED, "CATHETER BENDING/KINKING JUST BELOW HUB WHERE SECURED BY SUTURES IMPAIRING THE CATHETER¿S ABILITY TO FLOW. THE SUTURES HAD TO BE CUT AND CATHETER STRAIGHTENED OUT TO USE. NO PATIENT INJURY REPORTED. THIS REPORT IS REGARDING PATIENT 3.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5906673 ↗
• MalfunctionAug 26, 2016Kinked; Split

  ON 08/16/2016- PER SALES REPRESENTATIVE, THE FACILITY REPORTED AN ISSUE WITH A ZENYSIS DUAL LUMEN CATHETER THAT WAS INSERTED IN A PATIENT. ON (B)(6) 2016 - THE PICTURE RECEIVED APPEARS TO SHOW A SPLIT IN THE CATHETER NEAR THE INSERTION SITE. ON (B)(6) 2016 - PER THE SALES REPRESENTATIVE: "THE CATHETER IS COMPLETELY KINKED OVER AT THE BASE OF THE HUB WHERE THE CATHETER SHAFT BEGINS. YOU CAN SEE THE SEPTUM BETWEEN THE TWO LUMENS WHERE THERE IS PRESSURE ON THE CATHETER." ON 08/18/2016- ADDITIONAL INFORMATION FROM SALES REPRESENTATIVE STATED, "CATHETER BENDING/KINKING JUST BELOW HUB WHERE SECURED BY SUTURES IMPAIRING THE CATHETER'S ABILITY TO FLOW. THE SUTURES HAD TO BE CUT AND CATHETER STRAIGHTENED OUT TO USE. NO PATIENT INJURY REPORTED. THIS REPORT IS REGARDING PATIENT 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5906668 ↗
• MalfunctionAug 26, 2016Bent; Kinked; Split

  ON 08/16/2016 - PER SALES REPRESENTATIVE, THE FACILITY REPORTED AN ISSUE WITH A ZENYSIS DUAL LUMEN CATHETER THAT WAS INSERTED IN A PATIENT. ON 08/17/2016 - THE PICTURE RECEIVED APPEARS TO SHOW A SPLIT IN THE CATHETER NEAR THE INSERTION SITE. ON 08/17/2016 - PER THE SALES REPRESENTATIVE: "THE CATHETER IS COMPLETELY KINKED OVER AT THE BASE OF THE HUB WHERE THE CATHETER SHAFT BEGINS. YOU CAN SEE THE SEPTUM BETWEEN THE TWO LUMENS WHERE THERE IS PRESSURE ON THE CATHETER." ON 08/18/2016 - ADDITIONAL INFORMATION FROM SALES REPRESENTATIVE STATED, "CATHETER BENDING/KINKING JUST BELOW HUB WHERE SECURED BY SUTURES IMPAIRING THE CATHETERABILITY TO FLOW. THE SUTURES HAD TO BE CUT AND CATHETER STRAIGHTENED OUT TO USE. NO PATIENT INJURY REPORTED. THIS REPORT IS REGARDING PATIENT 1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5906623 ↗