Midline Catheter
General Hospital · 21 CFR 880.5200
The catheter is inserted into the peripheral vascular system for infusion of fluids and medications for less than 28 days.
Recent MDR events
983 adverse event reports on file
- Power MidlineJul 31, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05411
- Power MidlineJul 31, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05410
- PROVENAJul 9, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04824
- POWERMIDLINEJul 8, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04788
- POWERMIDLINEJul 8, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04789
- POWERMIDLINEJul 8, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04787
- POWERMIDLINEJul 8, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04792
- POWERMIDLINEJul 1, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04644
- POWERMIDLINEJun 23, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04353
- POWERMIDLINEJun 17, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-04181
Event type breakdown
Recalls
10 recall events for this product code
- Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
CK000727 PowerMidline Catheter 4 Fr Single-Lumen
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2662-2026 · View FDA record ↗ - Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
CK000980A PowerMidline Catheter 4 Fr Dual-Lumen
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2663-2026 · View FDA record ↗ - Bard Access Systems, Inc.Open, ClassifiedJul 2, 2026
CK000880 Provena Midline Catheter 4 Fr Dual-Lumen
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2667-2026 · 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-2387-2026 · View FDA record ↗ - ARROW INTERNATIONAL Inc.TerminatedOct 19, 2022
ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venou
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).
Z-0102-2023 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedUnknown
Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and pow
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
Z-0294-2021 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedUnknown
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and powe
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
Z-0295-2021 · View FDA record ↗ - Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.TerminatedUnknown
4Fr x 20cm Single Lumen CT
Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Z-0585-2020 · View FDA record ↗ - Arrow International IncTerminatedUnknown
Arrowg+ard Blue Advance Midline
Lidstock states the incorrect expiration date for the product
Z-1818-2019 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedUnknown
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length
Iincorrectly packaged without the required lidocaine as labeled
Z-1946-2020 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
C.r. Bard, Inc.
COVINGTON, GA, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Angiodynamics, Inc
Queensbury, NY, US
Isomedix Operations, Inc.
Temecula, CA, US
C.r. Bard, Inc.
MADISON, GA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Synergy Health Ast, Srl
Alajuela, CR
Bard Access Systems, Inc.
Salt Lake City, UT, US
Isomedix Operations Inc
El Paso, TX, US
Bard Reynosa S.a. De C.v.
REYNOSA Tamaulipas, MX
Medical Components Inc
HARLEYSVILLE, PA, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Spectrum Vascular
White Plains, NY, US
Isomedix Operations Inc.
Northborough, MA, US
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Atl Technology Llc
Springville, UT, US
Arrow International, Llc (subsidiary Of Teleflex Incorporated)
Wyomissing, PA, US
510(k) clearances
13 clearances for this product code
- Terumo Medical Products (Hangzhou) Co., Ltd.Dec 18, 2025
K252402 · Midline Catheter
- Arrow International, LLC Subsidiary of Teleflex IncorporatedSep 2, 2022
K213855 · Arrow Pressure Injectable Midline Catheter
- C.R. Bard, Inc.May 13, 2022
K213203 · Provena(TM) Midline Catheter
- Piper Access, LLCAug 27, 2021
K210047 · Stiletto Extended Dwell Catheter
- Pfm Medical, Inc.Oct 28, 2019
K192802 · primeMidline Catheters
- Vygon USANov 2, 2018
K181208 · Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
- Pfm Medical, Inc.Mar 7, 2018
K173114 · primeMidline Catheters
- Medcomp (Dba Medical Components, Inc.)Dec 15, 2017
K171483 · ArchFlo CT Midline