Catheter, Ventricular, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4200
Recent MDR events
32 adverse event reports on file
- HEMOVAC DRAINJul 6, 2026InjuryC.r. Bard, Inc.MW5190322
- ARGYLEJun 5, 2026MalfunctionCardinal Health, Inc.25407755
- AXIOM MEDICAL CHEST TUBEMar 4, 2025MalfunctionUnkMW5167185
- COVIDIEN ARGYLE SILICONE THORACIC CATHETEROct 28, 2024MalfunctionCovidienMW5161829
- ARGYLEAug 15, 2024MalfunctionCardinal Health, Inc.1423537-2024-00116
- UNKNOWNJun 29, 2023InjuryAxiom Medical, Inc.0002020735-2023-00001
- UNKNOWNJun 29, 2023InjuryAxiom Medical Inc0002020735-2023-00002
- AXIOM ATRAUM WITH CLOT STOP THORACIC ANGLE SILICONE CATHETERNov 22, 2021InjuryAxiom Medical Inc2020735-2021-00001
- AXIOM ATRAUM THORACIC CATHETEROct 22, 2021MalfunctionAxiom Medical, Inc.MW5104904
- HYDRAGLIDE SILICONE CATHETERS STRAIGHTMar 21, 2020MalfunctionAtrium Medical Corporation3011175548-2020-00446
Event type breakdown
Recalls
20 recall events for this product code
- Concentric Medical IncTerminatedJan 12, 2011
Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA
Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
Z-0899-2011 · View FDA record ↗ - Atrium Medical CorporationTerminatedOct 7, 2010
HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight
Mislabeled: One lot of 24Fr Straight Catheters packaged and labeled as 32Fr Straight Catheters.
Z-0019-2011 · View FDA record ↗ - Atrium Medical CorporationTerminatedOct 7, 2010
HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight
Mislabeled: One lot of 32Fr Straight Catheters packaged and labeled as 24Fr Straight Catheters.
Z-0020-2011 · View FDA record ↗ - Atrium Medical CorporationTerminatedAug 14, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
Z-1830-2008 · View FDA record ↗ - Atrium Medical CorporationTerminatedAug 14, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
Z-1831-2008 · View FDA record ↗ - Atrium Medical CorporationTerminatedAug 14, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
Z-1832-2008 · View FDA record ↗ - Atrium Medical CorporationTerminatedAug 14, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
Z-1833-2008 · View FDA record ↗ - Atrium Medical CorporationTerminatedAug 14, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
Z-1834-2008 · View FDA record ↗ - Atrium Medical CorporationTerminatedAug 14, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
Z-1835-2008 · View FDA record ↗ - Atrium Medical CorporationTerminatedAug 14, 2008
HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip,
Heparin-coated Thoracic Catheters were manufactured with heparin allegedly contaminated with oversulfated chondroitin sulfate
Z-1836-2008 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Shandong Zhushi Pharmaceutical Group Co., Ltd
Heze Shandong, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Degania Silicone, Ltd.
DEGANIA BET Northern, IL
Sterigenics U.s., Llc
Charlotte, NC, US
Sterigenics Us Llc
Gurnee, IL, US
Axiom Medical, Inc.
TORRANCE, CA, US
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Jfd-pk Medical Llc
Center Valley, PA, US
Pleural Dynamics, Inc.
Minnetonka, MN, US
Sterigenics U.s., Llc
Corona, CA, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Genesis Industries, Inc.
ELMWOOD, WI, US
Jiangsu Hanheng Medical Technology Co., Ltd
Changzhou Jiangsu, CN
Isomedix Operations, Inc.
Libertyville, IL, US
Alleva Medical Devices
Brea, CA, US
Rece International Corp.
Miami, FL, US
Productos Para El Cuidado De La Salud
NOGALES Sonora, MX
Covidien
TIJUANA, B.C. Mexico, MX
Nanning Tecbod Biological Technology Co.,ltd
Nanning Guangxi, CN
Terumo Bct Sterilization Services, Inc.
LAKEWOOD, CO, US
Holmed Llc
Attleboro, MA, US
C.r. Bard, Inc.
COVINGTON, GA, US
Gcmedica Enterprise Ltd.(wuxi)
WUXI Jiangsu, CN
510(k) clearances
27 clearances for this product code
- Atrium Medical Corp.Sep 13, 1991
K912645 · ATRIUMS PDR THORACIC CATHETER
- Axiom, Inc.Feb 17, 1989
K883887 · AXIOM ATRAUM WOUND DRAINS
- Sheridan Catheter Corp.May 18, 1988
K881873 · INTRODUCTION/DRAINAGE CATHETER & ACCESS
- Uresil Corp.Mar 14, 1988
K880895 · URESIL WOUND DRAIN TROCAR
- Genesis Industries, Inc.Feb 16, 1988
K880376 · NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP
- Gish Biomedical, Inc.Oct 28, 1987
K873377 · CLOSED CHEST DRAINAGE SET W/SUTURES
- H.W. Andersen Products, Inc.Jul 23, 1987
K872460 · AN3000 MAHONEY DRAIN
- H.W. Andersen Products, Inc.Jul 21, 1987
K872459 · AN3100 MULHOLLAND DRAIN