BEUDAMED
    28 results · 11ms · Sources: EU EUDAMED, US FDA

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    smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    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

    FDA Recall
    Open, Classified ·Smiths Medical ASD, Inc.·Product code LJT·February 13, 2025

    THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardiac ablation.

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code OAD·September 7, 2022

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OGD·May 15, 2023

    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Model Number: ART905; c. CATHETERLESS INSERTION KIT, Model Number: CVI4510; d. OR CATHETER INSERTION SETUP PACK, Model Number: ECVC7165A; e. VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number: STCVC01145B; f. VANTEX TRIPLE LUMEN BUNDLE, Model Number: STCVC2000;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFD·May 15, 2023

    Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.

    FDA Recall
    Open, Classified ·Medtronic, Inc.·Product code OAD·March 11, 2026

    Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; 3) CHILDRENS INFANT SP TRAY, Pack Number DYNDA2906; 4) ULTRASOUND GUIDE BREAST BIOPSY, Pack Number DYNDH1319; 5) BIOPSY TRAY, Pack Number DYNDH1693A; 6) PACK,ULTRASOUND, Pack Number DYNDL1461; 7) LUMBAR PUNCTURE TRAY, Pack Number DYNJTS4306; 8) ARTHROGRAM TRAY, Pack Number SPEC0143A; 9) PD CATH KIT, Pack Number UVT1205

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFD·April 8, 2024

    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OFD·May 18, 2023

    Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·June 20, 2018

    IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OAD·November 28, 2018