Philips Electronics North America Corporation - Allura Xper R8.x.25.5 (only with a FlexVision large screen monitor) - Class 2 Recall
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, eg peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placement, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional minimally invasive procedures (such as PTCA, stent placing, athere...
Source: Medical Device Recalls - May 2, 2018 Category: Medical Devices Source Type: alerts
Cook Inc. - Advance 35LP LowProfile PTA Balloon Dilatation Catheter - Class 2 Recall
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 26, 2018 Category: Medical Devices Source Type: alerts
Angiodynamics Inc. (Navilyst Medical Inc.) - Class 2 Recall
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 18, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Allura Xper FD and and Xper FD ORT - Class 2 Recall
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angi...
Source: Medical Device Recalls - February 25, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Allura Xper Philips Xray Systems - Class 2 Recall
Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemake...
Source: Medical Device Recalls - February 25, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Philips Allura Xper R9 and Azurion R1.1 - Class 2 Recall
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and ele...
Source: Medical Device Recalls - December 19, 2017 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure - Solarice Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2017 Category: Medical Devices Source Type: alerts
Medtronic Inc., Cardiac Rhythm and Heart Failure - Euphora Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2017 Category: Medical Devices Source Type: alerts
Medtronic Vascular Galway DBA Medtronic Ireland - Euphora Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2017 Category: Medical Devices Source Type: alerts
Medtronic Vascular Galway DBA Medtronic Ireland - Solarice Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 21, 2017 Category: Medical Devices Source Type: alerts
DeRoyal Industries Inc - Dolphin Inflation Device - Class 2 Recall
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 30, 2017 Category: Medical Devices Source Type: alerts
Abbott Vascular - NC Trek RX Coronary Dilatation Catheter - Class 1 Recall
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 13, 2017 Category: Medical Devices Source Type: alerts
Cardiovascular Systems Inc - ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire - Class 2 Recall
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a ...
Source: Medical Device Recalls - April 11, 2017 Category: Medical Equipment Source Type: alerts
Cardiovascular Systems Inc - DIAMONDBACK 360 Peripheral Orbital Atherectomy System - Class 2 Recall
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as th...
Source: Medical Device Recalls - February 23, 2017 Category: Medical Equipment Source Type: alerts
Philips Electronics North America Corporation - Philips Allura Xper FD20 R8.2 722028 - Class 2 Recall
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP). (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 21, 2017 Category: Medical Equipment Source Type: alerts
