Merit Medical Systems, Inc. - Merit Custom Kit - Class 2 Recall
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several syringes, table covers, stopcocks, inflation device, and gauze (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 30, 2020 Category: Medical Devices Source Type: alerts
Bard Peripheral Vascular Inc - Conquest PTA Balloon Dilatation Catheter - Class 2 Recall
Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: 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. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 9, 2020 Category: Medical Devices Source Type: alerts
ev3 Inc. - Pacific Xtreme (PTCA Balloon Dilation Catheter) - Class 2 Recall
Pacific Xtreme (PTCA Balloon Dilation Catheter) (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 1, 2020 Category: Medical Devices Source Type: alerts
Spectranetics Corporation - Spectranetics AngioSculpt PTCA Scoring Balloon Catheter - Class 2 Recall
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 27, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - NC Emerge OverTheWire (OTW) and NC Emerge Monorail (MR) PTCA Dilatation Catheters - Class 2 Recall
NC Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493926708350, NC EMERGE MR US 3.50MM X 8MM; 2. REF/Catalog No. H7493927608350, NC EMERGE MR OUS 3.50MM X 8MM; 3. REF/Catalog No. H7493927608400, NC EMERGE MR OUS 4.00MM X 8MM; 4. REF/Catalog No. H7493927612200, NC EMERGE MR OUS 2.00MM X 12MM; 5. REF/Catalog No. H7493926712250, NC EMERGE MR US 2.50MM X 12MM; 6. REF/Catalog No. H7493927612250, NC EMERGE MR OUS 2.50MM X 12MM; 7. REF/Catalog No. H7493926712270, NC EMERGE MR US 2.75MM X 12MM; 8. REF/Catalog No. H7493926712320, NC EME...
Source: Medical Device Recalls - November 27, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Emerge OverTheWire and Emerge Monorail PTCA Dilatation Catheters - Class 2 Recall
Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; 3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; 4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM; 5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm; 6. REF/Catalog No. H7493918912300, EMERGE MR US 3.00MM X 12MM; 7. REF/Catalog No. H7493919312300, EMERGE MR, OUS 3.00mm X 12mm; 8. REF/Catalog No. H7493918915150, EMERGE MR US 1.50MM X 15MM...
Source: Medical Device Recalls - November 27, 2019 Category: Medical Devices Source Type: alerts
Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended 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. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts
Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended 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. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts
Cook Inc. - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER - Class 1 Recall
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended 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. Not for use in the cerebral or coronary vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 18, 2019 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - Stingray Guidewire - Class 2 Recall
Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2019 Category: Medical Devices Source Type: alerts
Cordis Corporation - POWERFLEX PRO Percutaneous Transluminal Angioplasty (PTA) Catheter - Class 2 Recall
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 7, 2018 Category: Medical Devices Source Type: alerts
Cardiovascular Systems Inc - Orbital Atherectomy System (OAS) Saline Infusion Pump - Class 2 Recall
CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The Indications for Use for the peripheral and coronary systems are provided below: Peripheral: The DIAMONDBACK 360¿ and STEALTH Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and...
Source: Medical Device Recalls - September 12, 2018 Category: Medical Devices Source Type: alerts
Philips Healthcare - Centron - Class 2 Recall
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2018 Category: Medical Devices Source Type: alerts
Philips Healthcare - Allura Xper - Class 2 Recall
Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2018 Category: Medical Devices Source Type: alerts
Philips Healthcare - UNIQ - Class 2 Recall
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA,stent placing,atherectomies), pacemaker implantat ions, and electrophysiology (EP). Non-vascular interventions such as drainages,biopsies and vertebroplasties procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 26, 2018 Category: Medical Devices Source Type: alerts
