Coronary Artery Bypass Graft Alerts This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Spectranetics Corporation - ELCA Coronary Atherectomy Catheter. - Class 3 Recall
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts

Spectranetics Corporation - Turbo Elite Atherectomy Catheter - Class 2 Recall
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 29, 2016 Category: Medical Equipment Source Type: alerts

NOVADAQ TECHNOLOGIES INC. - SK6000 PAQ drape pouch - Class 2 Recall
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 9, 2016 Category: Medical Equipment Source Type: alerts

DeRoyal Industries Inc - Various DeRoyal Surgical Kits - Class 2 Recall
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7959.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custome surgical kits: 1) Open Heart Pack Pgybk, ref 89-5792.10 2) Open Heart A&B Pgybk, ref 89-7626.02 3) Open Heart A&B Pgybk, ref 89-7626.03 4) Open Heat Pack A&B Pgybk, ref 89-8440.01 5) Open Heart Pack A&B Pgybk, ref 89-8440.02 (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 3, 2015 Category: Medical Equipment Source Type: alerts

Resource Optimization & Innovation Llc - Regard Custom Surgical Pack - Class 2 Recall
Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2015 Category: Medical Equipment Source Type: alerts

Resource Optimization & Innovation Llc - Regard Custom Surgical Pack - Class 2 Recall
Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2015 Category: Medical Equipment Source Type: alerts

Resource Optimization & Innovation Llc - Regard - Class 2 Recall
Regard (tm), Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2015 Category: Medical Equipment Source Type: alerts

Resource Optimization & Innovation Llc - Regard - Class 2 Recall
Regard (tm), Item Number: 800208002; Sterile, CV0361B - CABG A&B. Used in cardiovascular surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 22, 2015 Category: Medical Equipment Source Type: alerts

DeRoyal Industries Inc - Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves - Class 2 Recall
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-3808; NEURO CRANIOTOMY TRAY, REF 89-3809; BASIC SET UP TRAY, REF 89-4137; BASIC PACK, REF 89-4798; SJCHS EXTREMITY TRAY, REF 89-4...
Source: Medical Device Recalls - June 26, 2015 Category: Medical Equipment Source Type: alerts

Maquet Cardiovascular, LLC - Vasoview Hemopro Endoscopic Vessel Harvesting System - Class 2 Recall
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. ...
Source: Medical Device Recalls - December 7, 2013 Category: Medical Equipment Source Type: alerts

Edwards Lifesciences, LLC - Anastaflo Intravascular Shunt - Class 2 Recall
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts30. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2013 Category: Medical Equipment Source Type: alerts