Cordis Corporation - EMPIRA (TM) RX PTCA Dilatation Catheter - Class 2 Recall
Cordis EMPIRA RX PTCA Dilatation Catheter (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 29, 2014 Category: Medical Equipment Source Type: alerts
Cardiovascular Systems, Inc. - Diamondback 360 Peripheral Orbital Atherectomy System. - Class 1 Recall
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DPB-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system 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 system is a percutaneous orbital atherectomy system indicated as a therapy in patients with oc...
Source: Medical Device Recalls - August 15, 2014 Category: Medical Equipment Source Type: alerts
Cordis Corporation - Cordis EMPIRA RX PTCA Dilatation Catheter - Class 2 Recall
Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 12, 2014 Category: Medical Equipment Source Type: alerts
Boston Scientific Corporation - iLab Ultrasound Imaging System - Class 2 Recall
iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Product Usage: The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy. Automatic Pullback is indicated for the following use cases: The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator. The physician/operator wants to make linear distance determi...
Source: Medical Device Recalls - April 23, 2014 Category: Medical Equipment Source Type: alerts
Cardiovascular Systems, Inc. - Diamondback 360 Coronary Orbital Atherectomy System - Class 3 Recall
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 27, 2014 Category: Medical Equipment Source Type: alerts
Medtronic Vascular, Inc. - NC Sprinter; Rapid Exchange Balloon Dilatation Catheter - Class 2 Recall
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaqu...
Source: Medical Device Recalls - October 1, 2013 Category: Medical Equipment Source Type: alerts
Boston Scientific Corporation - Boston Scientific, Small Peripheral Cutting BalloonTM - Class 2 Recall
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #001BPM4015140F0, Catalogue # BPM4015140F & UPN # M001PCBM4015140F0, Catalogue # PCBM4015140F. 2) 4.00mm x 15mm Small Peripheral Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # M001PCBO4015140F0, Catalogue # PCBO4015140F. (So...
Source: Medical Device Recalls - September 4, 2013 Category: Medical Equipment Source Type: alerts
Bard Peripheral Vascular Inc - PTA Balloon Dilatation Catheters - Class 2 Recall
BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess¿ PTA Balloon Dilatation Catheters are supplied ste...
Source: Medical Device Recalls - June 13, 2013 Category: Medical Equipment Source Type: alerts
