Needle, Catheter
General, Plastic Surgery · 21 CFR 878.4200
Recent MDR events
394 adverse event reports on file
- MAK-NV-007/KRAJul 20, 2026InjuryMerit Medical Systems, Inc.3011642792-2026-00117
- ACCUSTICK NEEDLEJun 11, 2026MalfunctionBoston Scientific Corporation2124215-2026-31307
- MAK-NV¿Jan 7, 2026MalfunctionMerit Medical Systems, Inc.1721504-2026-00790
- YUEH CENTESIS DISPOSABLE CATHETER NEEDLEDec 1, 2025MalfunctionCook IncorporatedMW5179629
- RING DRAINAGE CATHETER NEEDLE SETNov 21, 2025InjuryCook Inc1820334-2025-01456
- RINGNov 14, 2025MalfunctionCook Incorporated23554332
- ACCUSTICK NEEDLEJul 24, 2025MalfunctionBoston Scientific Corporation2124215-2025-48610
- MAK-NV¿Jul 16, 2025MalfunctionMerit Medical Systems3011642792-2025-00083
- MAK-NV¿Jul 16, 2025InjuryMerit Medical Systems3011642792-2025-00058
- GCB NEEDLE, CATHETERJun 24, 2025InjuryCook Inc1820334-2025-00757
Event type breakdown
Recalls
8 recall events for this product code
- Cook IncorporatedOpen, ClassifiedApr 12, 2024
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Z-1527-2024 · View FDA record ↗ - Custom Healthcare Systems, Inc.TerminatedJul 17, 2015
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The NON-STERILE OUTSIDE "PIGGYBACKED" PACKAGE mistakenly contains ITEM #8881579121 - Syringe prefilled, Saline Flush, 09% Sodium Chloride and is a NONSTERILE PRODUCT that CANNOT BE DROPPED INTO THE STERILE FIELD.
Z-2096-2015 · View FDA record ↗ - Pfm Medical IncTerminatedDec 12, 2014
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Z-0560-2015 · View FDA record ↗ - Pfm Medical IncTerminatedDec 12, 2014
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Z-0566-2015 · View FDA record ↗ - Pfm Medical IncTerminatedDec 12, 2014
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Z-0567-2015 · View FDA record ↗ - Carefusion 2200 IncTerminatedSep 11, 2013
*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA;
Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.
Z-2193-2013 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedUnknown
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17)
The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
Z-1795-2020 · View FDA record ↗ - Argon Medical Devices, IncTerminatedUnknown
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaq
Tungsten coils of the guidewire included in the introducer kit were detaching.
Z-2109-2020 · View FDA record ↗
Registered firms
85 firms currently registered for this product code
Auris Health, Inc
Santa Clara, CA, US
Medical Components Inc
HARLEYSVILLE, PA, US
Sterigenics U.s., Llc
Charlotte, NC, US
Vascular Solutions Llc
Maple Grove, MN, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Isomedix Operations, Inc.
Temecula, CA, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Merit Maquiladora Mexico, S. De R.l. De C.v.
Tijuana Baja California, MX
Sterigenics U.s., Llc
Atlanta, GA, US
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
Synergy Health Ast, Srl
Alajuela, CR
Deroyal Industries, Inc.
POWELL, TN, US
Promepla S.a.m
MONACO Monaco-Ville, MC
B. Braun Medical Inc.
BETHLEHEM, PA, US
Sterigenics U.s., Llc
Queensbury, NY, US
Teleflex Medical Llc
Morrisville, NC, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Merit Medical Systems, Inc.
South Jordan, UT, US
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Integra Lifesciences Corporation
CINCINNATI, OH, US
Y.jacobs Medical Inc.
Seongnam-si Gyeonggi, KR
510(k) clearances
8 clearances for this product code
- B.Braun Medical, Inc.Nov 12, 2015
K150800 · Valved Safety Centesis Catheter
- Allegiance Healthcare Corp.Jan 28, 1998
K974146 · PARACENTESIS CATHETER DEVICE
- Medical Dynamics, Inc.Jul 22, 1993
K930568 · ADAIR/VERESS NEEDLE INTRODUCER SET
- Symbiosis Corp.Aug 4, 1992
K923028 · TURKEL PNEUMOTHORAX KIT
- Medical Dynamics, Inc.Apr 20, 1990
K900374 · ADAIR/VERESS NEEDLE INTRODUCER SET
- Concord Laboratories, Inc.Nov 13, 1985
K854327 · SUBCUTANEOUS TUNNELING NEEDLES & HANDLES
- Manan Manufacturing Co., Inc.Jun 27, 1985
K852428 · MANAN EPIDURAL NEEDLE
- Jelco LaboratoriesAug 23, 1978
K780896 · NEEDLES, DESIGN CHANGE, IV CATHETERS