Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Gastroenterology, Urology · 21 CFR 876.5630
For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Recent MDR events
178 adverse event reports on file
- PERITX PERITONEAL CATHETER MINI KITJul 20, 2026MalfunctionCarefusion, Inc1423507-2026-00107
- ROCKETJul 10, 2026MalfunctionRocket Medical Plc3002808026-2023-00013
- PERITX PERITONEAL CATHETER MINI KITJul 10, 2026MalfunctionCarefusion, Inc1423507-2026-00103
- PERITX PERITONEAL CATHETER MINI KITJul 10, 2026MalfunctionCarefusion, Inc1423507-2026-00102
- PERITX PERITONEAL CATHETER MINI KITJun 5, 2026MalfunctionCarefusion, Inc1423507-2026-00081
- ASPIRA®May 1, 2026MalfunctionMerit Medical Systems, Inc.3011642792-2026-00042
- ASPIRA®May 1, 2026MalfunctionMerit Medical Systems, Inc.3011642792-2026-00049
- ASPIRA®May 1, 2026MalfunctionMerit Medical Systems, Inc.3011642792-2026-00037
- ASPIRA®May 1, 2026MalfunctionMerit Medical Systems, Inc.3011642792-2026-00040
- ASPIRA®May 1, 2026MalfunctionMerit Medical Systems, Inc.3011642792-2026-00039
Event type breakdown
Recalls
13 recall events for this product code
- Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1908-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1909-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1910-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1911-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1912-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1913-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1914-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1915-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1916-2023 · View FDA record ↗ - Merit Medical Systems, Inc.Open, ClassifiedJun 14, 2023
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
There is a potential that valve assemblies will not open. preventing fluid from draining.
Z-1917-2023 · View FDA record ↗
Registered firms
47 firms currently registered for this product code
Worldwide Supplies Limited
Hong Kong, HK
C.r. Bard, Inc.
COVINGTON, GA, US
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Carefusion 2200, Inc.
Vernon Hills, IL, US
Merit Medical Uk Limited
Earley Reading, GB
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Merit Medical Systems, Inc.
South Jordan, UT, US
Alleva Medical (d.g.) Ltd
Dongguan City Guangdong, CN
Veenak International Limited
BIRMINGHAM, GB
Palm Medical International Bv
Buggenhout Oost-Vlaanderen, BE
Pfm Medical, Inc
Carlsbad, CA, US
Isomedix Operations, Inc.
Temecula, CA, US
Merit Medical Canada Ltd.
Markham Ontario, CA
C.r. Bard, Inc.
MADISON, GA, US
Cbr Enterprise Limited
Hong Kong, HK
Terumo Bct Sterilization Services, Inc.
LAKEWOOD, CO, US
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Turnxon Precision Co., Ltd
Dongguan Guangdong, CN
Bearpac Medical, Llc
Moultonborough, NH, US
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
510(k) clearances
15 clearances for this product code
- Pfm Medical, Inc.Jan 14, 2025
K241278 · ASEPT® Glide Peritoneal Drainage System
- Bard Peripheral Vascular, Inc.Dec 6, 2024
K241946 · PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50-
- Bearpac MedicalNov 24, 2023
K230319 · Passio Pump Drainage System
- Pfm Medical, Inc.May 2, 2023
K221779 · ASEPT Peritoneal Drainage System
- Merit Medical Systems, Inc.Dec 14, 2021
K212675 · Aspira Peritoneal Drainage System
- Care FusionOct 21, 2020
K201155 · PleurX Peritoneal Catheter System
- Rocket Medical PlcNov 14, 2016
K162457 · Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit
- Care FusionNov 3, 2016
K160437 · PleurX Peritoneal Catheter System