3,445 results found for catheter
Page 10 of 138
Abbott
Class II Ongoing FDA Details
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Reason: Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure...
Conavi Medical Inc.
Class I Ongoing FDA Details
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The No...
Reason: Due to manufacturing issues there is a potential for the catheter sheath to detach.
Avanos Medical, Inc.
Class I Ongoing FDA Details
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F,...
Reason: Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.
Class I Ongoing FDA Details
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow ...
Reason: Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.
Class I Ongoing FDA Details
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2210-5 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, DSE Component: N...
Reason: Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.
Class I Ongoing FDA Details
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 20083 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Elbow ...
Reason: Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.
Class I Ongoing FDA Details
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 220135 Software Version: N/A Product Description: Ballard Closed Suction System for Adults, 14 F, T-Piece Componen...
Reason: Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.
Class I Ongoing FDA Details
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 22714183-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F...
Reason: Lack of sterility assurance for closed suction catheter systems
Bard Access Systems, Inc.
Class I Ongoing FDA Details
BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 217...
Reason: Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased mater...
Avanos Medical, Inc.
Class I Ongoing FDA Details
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 227-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE...
Reason: Lack of sterility assurance for closed suction catheter systems
Avanos Medical, Inc.
Class I Ongoing FDA Details
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 198 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 8 F, Y-Adapte...
Reason: Lack of sterility assurance for closed suction catheter systems
Qapel Medical Inc.
Class I Ongoing FDA Details
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration ...
Reason: Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing FDA Details
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Reason: Devices may have higher than expected amounts of bacterial endotoxin.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
B Braun Medical Inc
Class II Ongoing FDA Details
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Reason: Increased risk for valve housing detachment causing leakage.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, Inc.
Class I Ongoing FDA Details
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.