Catheter, Hemodialysis, Triple Lumen, Non-implanted
Gastroenterology, Urology · 21 CFR 876.5540
Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Recent MDR events
825 adverse event reports on file
- BD POWER TRIALYSISJul 21, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05138
- POWER TRIALYSIS SLIM CATHJul 16, 2026InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2026-05040
- BARD POWER-TRIALYSIS DIALYSIS CATHETERJul 14, 2026InjuryBard Access Sysems, Inc.MW5190729
- POWER TRIALYSISJul 10, 2026InjuryC.r. Bard, Inc. (basd) -30062607403006260740-2026-04870
- POWER TRIALYSISJun 16, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04154
- POWER-TRIALYSIS CATHETERJun 8, 2026MalfunctionBard Access Systems, Inc.25427159
- POWERTRIALYSIS SLIMCATHMay 29, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-03720
- POWERTRIALYSISMay 28, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-03709
- POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETERMay 6, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-03203
- ARROW AHDC KIT: 3-L 12 FR X 16 CMMay 5, 2026MalfunctionArrow International Llc9680794-2026-00360
Event type breakdown
Recalls
38 recall events for this product code
- Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2660-2026 · View FDA record ↗ - Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2661-2026 · View FDA record ↗ - ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2374-2026 · View FDA record ↗ - Mozarc Medical US LLCOpen, ClassifiedNov 4, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
A potential issue with the seal integrity of header bag packaging.
Z-0421-2026 · View FDA record ↗ - Mozarc Medical US LLCOpen, ClassifiedNov 4, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
A potential issue with the seal integrity of header bag packaging.
Z-0422-2026 · View FDA record ↗ - Mozarc Medical US LLCOpen, ClassifiedNov 4, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
A potential issue with the seal integrity of header bag packaging.
Z-0423-2026 · View FDA record ↗ - Mozarc Medical US LLCOpen, ClassifiedNov 4, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
A potential issue with the seal integrity of header bag packaging.
Z-0424-2026 · View FDA record ↗ - Mozarc Medical US LLCOpen, ClassifiedNov 4, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
A potential issue with the seal integrity of header bag packaging.
Z-0425-2026 · View FDA record ↗ - Mozarc Medical US LLCOpen, ClassifiedNov 4, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
A potential issue with the seal integrity of header bag packaging.
Z-0426-2026 · View FDA record ↗ - Covidien LPOpen, ClassifiedAug 11, 2023
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
Z-2367-2023 · View FDA record ↗
Registered firms
51 firms currently registered for this product code
Cardinal Health Costa Rica, S.a.
-- Alajuela, CR
Covidien
TIJUANA, B.C. Mexico, MX
Arrow International, Llc (subsidiary Of Teleflex Incorporated)
Wyomissing, PA, US
Paragon Medical - Mansfield, Bridgemedica
Mansfield, MA, US
Covidien Llc
MANSFIELD, MA, US
Isomedix Operations, Inc.
Temecula, CA, US
Medical Components Inc
HARLEYSVILLE, PA, US
C.r. Bard, Inc.
MADISON, GA, US
C.r. Bard, Inc.
COVINGTON, GA, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Sterigenics U.s., Llc
Queensbury, NY, US
Mozarc Medical Us Llc
Mansfield, MA, US
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Isomedix Operations Inc
El Paso, TX, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
510(k) clearances
12 clearances for this product code
- Medical Components, Inc. (dba MedComp)Nov 16, 2023
K232945 · Trio-CT® Triple Lumen Catheter w/ Curved Extensions
- Health Line International CorporationJan 13, 2023
K222170 · Power Acute Triple Lumen Hemodialysis Catheter
- Medical Components, Inc. (dba MedComp)Jun 14, 2019
K183219 · Trio-CT Triple Lumen Catheter
- Medical Components, Inc. (dba MedComp)Jul 5, 2018
K181175 · 12F Tri-Flow Triple Lumen Catheter
- Arrow International, Inc. (Subsidiary of Teleflex, Inc.)Jul 24, 2015
K143102 · Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
- C.R. Bard, Inc.Jun 1, 2015
K141531 · POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
- C.R. Bard, Inc.Sep 24, 2014
K133456 · POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
- MedcompJun 11, 2013
K123292 · T3