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    Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass. Catalog Number: CB67532

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·May 9, 2008

    VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.

    FDA Recall
    Terminated ·Covidien LLC·Product code PJQ·April 28, 2015

    MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G

    FDA Recall
    Open, Classified ·Product code OES·April 27, 2026

    GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. K061163: For Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100IQ, Innova 2100IQ devices with Innova IVUS option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova IVUS Option: The Innova IVUS software option simplifies the clinical workflow associated with the use of Volcano IVUS products by: (1) automatically synchronizing the patient demographic information (patient name, date of birth, DICOM attributes etc.) from Innova system with an IVUS imaging system, (2) providing a remote access to commonly used IVUS functions from the Innova table side user interface, (3) displaying the IVUS images on the multi-monitor display of the Innova cathlab system. K091658: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MQB·August 16, 2012

    Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive Surface, for Vascular Cardiopulmonary Bypass. Catalog Number: CB68122

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·May 9, 2008

    Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This product is only available OUS. Catalog number: M470450E

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWF·May 9, 2008

    Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code MSD·June 8, 2022

    Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code MSD·June 8, 2022

    Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.

    FDA Recall
    Terminated ·Medtronic Cardiovascular Surgery-the Heart Valve Division·Product code NPT·August 3, 2016

    Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code MSD·June 8, 2022

    Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code MSD·June 8, 2022

    GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention angiography procedures. It is intended to replace fluoroscopic images obtained through the image intensifier technology. This device is not intended for mammography applications. The Innova 3100 system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, and optionally, rotational and angiography procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications. A new tilt table will support performing procedures like CO2 studies, Venography. The Digital Fluoroscopic Imaging System with Bolus Chasing option is indicated for use in generating fluoroscopic images of human anatomy for diagnostic and intervention; the option Bolus enables to perform subtraction angiography of lower limbs. This device is not intended for mammography applications. The Innova 2100-IQ system is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures, and optionally, rotational angiography procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology diagnostic and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. This device is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3T Option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova CT is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. Innova CT is intended for imaging bone and soft tissues as well as other internal body structures. Innova CT is not intended for mammography applications. For Innova 4100, Innova 4100IQ, Innova 3100, Innova 3100 IQ, Innova 2100IQ with Innova 3D or InnovaSpin option: The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Innova 3D is a software option which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. It is not intended for mammography applications. InnovaSpin is a software option that permits fast spin rotational angiography. It is not intended for mammography applications. :

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code OWB·December 11, 2013

    Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included); 2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform configuration; 4.) 404207-B Completed unit, matte finish, 220 Volt; 5.) 404207-USAB Completed unit, matte finish, 220 Volt, USA-style power cord; 6.) 404208-B Completed unit, matte finish, 110 Volt; and 7.) 404208-MP Completed unit, matte finish, 110 Volt, Multi-Platform configuration. The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

    FDA Recall
    Terminated ·Sybaritic, Inc·Product code GEX·April 12, 2008

    Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code OWB·September 4, 2014

    FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code MVR·December 28, 2020

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code DQX·July 19, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code DQX·July 19, 2022

    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code DQX·July 19, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code DQX·July 19, 2022

    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·Cook Incorporated·Product code DQX·July 19, 2022