BEUDAMED
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    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·September 13, 2017

    DriSate Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

    FDA Recall
    Terminated ·Rockwell Medical, Inc·Product code KPO·April 7, 2018

    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code NPT·February 12, 2014

    Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.

    FDA Recall
    Terminated ·Abbott Vascular·Product code DTL·January 7, 2011

    Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.

    FDA Recall
    Terminated ·Abbott Vascular·Product code DQX·January 7, 2011

    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000

    FDA Recall
    Terminated ·Intersurgical Inc·Product code CAI·April 25, 2018

    Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For use in cardiac diagnostic and therapeutic procedures.

    FDA Recall
    Terminated ·Abbott Vascular·Product code DQY·January 7, 2011

    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BZA·August 7, 2019

    Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code OUT·July 19, 2013

    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BZA·August 7, 2019

    Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1996030. Airway connector.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BZA·August 7, 2019

    Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.

    FDA Recall
    Terminated ·Intersurgical Inc·Product code BZA·August 7, 2019

    The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded into the injector head of the injection system.

    FDA Recall
    Terminated ·Bayer Medical Care, Inc.·Product code DXT·September 14, 2021

    -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.

    FDA Recall
    Terminated ·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code OUT·September 4, 2015

    Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000

    FDA Recall
    Terminated ·Intersurgical Inc·Product code CAE·August 29, 2022

    Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DYG·May 5, 2015

    Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Silicone Catheter, REF/Catalog No. 45-220, UPN/Material No. M001452200,

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LJT·September 27, 2006

    Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

    FDA Recall
    Terminated ·Convatec Inc.·Product code EXB·June 22, 2011

    Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150,

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code LJT·September 27, 2006

    Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2 small spikes, patient t-connector tubing & prime tube.

    FDA Recall
    Terminated ·Bayer Medical Care, Inc.·Product code DXT·October 5, 2020