BEUDAMED
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    HENRY SCHEIN, GYN PACK, Item No.570-2625

    FDA Recall
    Open, Classified ·Stradis Medical, LLC dba Stradis Healthcare·Product code PVX·November 2, 2022

    J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·April 20, 2020

    Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·April 20, 2020

    2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.

    FDA Recall
    Terminated ·Spectranetics Corp.·Product code MCW·January 15, 2016

    J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

    EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi

    FDA Recall
    Completed ·Philips Ultrasound Inc·Product code IYN·July 22, 2021

    Angiojet Spiroflex, Catheter, 135 cm, 4F, Single use only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA- (Spiroflex Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).

    FDA Recall
    Terminated ·Possis Medical, Inc·Product code MCX·May 1, 2007

    Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with Ethylene Oxide, POSSIS MEDICAL, INC. 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003 USA-- (XMI - Rapid Exchange Rheolytic Thrombectomy Catheter) is one component of the AngioJet Rheolytic Thrombectomy System (AngioJet System).

    FDA Recall
    Terminated ·Possis Medical, Inc·Product code DXE·May 1, 2007

    AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DXE·July 31, 2015

    BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·July 18, 2016

    BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·July 18, 2016

    BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·July 18, 2016

    BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.

    FDA Recall
    Terminated ·Bovie Medical Corporation·Product code GEI·July 18, 2016

    Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)

    FDA Recall
    Completed ·Philips Ultrasound, Inc.·Product code IYN·October 9, 2023

    EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231

    FDA Recall
    Completed ·Philips Ultrasound Inc·Product code IYO·August 6, 2021

    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity

    FDA Recall
    Terminated ·Elana, Inc.·Product code PAX·November 9, 2016