93 results · 24ms · Sources: EU EUDAMED, US FDA

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Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 6F or larger introducer sheath over the included 0.018" (0.45mm) guidewire. Sterilized with ethylene oxide. Manufactured by: Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369 USA.

FDA Recall
Terminated ·Vascular Solutions, Inc.·Product code DXE·November 20, 2009

AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. 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

Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy catheter is intended for use in removing arterial emboli.

FDA Recall
Terminated ·Arrow International Inc·Product code DXE·March 25, 2009

LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.

FDA Recall
Terminated ·LeMaitre Vascular, Inc.·Product code DXE·October 21, 2015

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthetic dialysis grafts

FDA Recall
Terminated ·Arrow International Inc·Product code DXE·September 20, 2021

Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479

FDA Recall
Open, Classified ·ConvaTec, Inc·Product code EXE·November 29, 2024

LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex Model: 1601-48

FDA Recall
Terminated ·Lemaitre Vascular, Inc.·Product code DXE·February 7, 2005

Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew shape when retracted, greatly expanding the surface areas to entrap fibrous material. The device is 80 cm in length and is available in 4F-6F diameters.

FDA Recall
Terminated ·Edwards Lifesciences, LLC·Product code DXE·July 6, 2017

LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex Model: 1601-38

FDA Recall
Terminated ·Lemaitre Vascular, Inc.·Product code DXE·February 7, 2005

Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli.

FDA Recall
Terminated ·Arrow International Inc·Product code DXE·July 7, 2016

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

FDA Recall
Terminated ·ConvaTec, Inc·Product code EXE·April 22, 2022

TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..

FDA Recall
Open, Classified ·LeMaitre Vascular, Inc.·Product code DXE·September 30, 2022

Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP

FDA Recall
Open, Classified ·Edwards Lifesciences, LLC·Product code DXE·October 6, 2022