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Balloon Catheter - Articles

AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation by FDA Posted Wed 08 Sep 2010 10:50am [Posted 09/08/2010] AUDIENCE: Cardiology, Risk Manager ISSUE: The AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters may become separated during use, and fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death. This recall i ... Read on »
Class I Medical Device Recall: AngioScore Inc. - AngioSculpt "EX" PTCA Scoring Balloon Catheter by Health & Human Services Posted Tue 07 Sep 2010 9:00pm Recall Class: Class I Date Recall Initiated: December 4, 2009 Product: AngioSculpt "EX" Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheter (all Part/REF Numbers 2034-XXYY with lot numbers less than F09060003). This recall only includes "EX" Catheters. This product was distributed ... Read on »
Class I Medical Device Recall: AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter by Health & Human Services Posted Wed 05 Jan 2011 12:00am Recall Class: Class I Date Recall Initiated: November 15, 2010 Product(s): The AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, multiple sizes. This recall includes the following model part (REF) numbers and includes all sizes and lot codes for each model listed: 2076-4020 2076-5020 207 ... Read on »
Class I Medical Device Recall: Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra- by Health & Human Services Posted Wed 26 Jan 2011 12:00am This is an update of FDA's public recall notice on Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System , which was issued on December 29, 2010. Additional information about the model and lot numbers af ... Read on »
AngioScore Incorporated Announces Worldwide Voluntary Field Removal of the AngioSculpt® PTA Scoring Balloon Catheter, 0.018 by FDA Posted Sun 09 Jan 2011 10:36am FOR IMMEDIATE RELEASE - On November 15, 2010 - AngioScore Incorporated, Fremont, CA initiated a worldwide recall of the AngioSculpt® PTA Scoring Balloon Catheter, 0.018” OTW, balloon sizes: 4.0x20mm, 5.0x20mm, and 6.0x20mm. This recall was initiated because of a small number of reports from the field of distal bond failure whic ... Read on »
Class I Medical Device Recall: Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra- by FDA Posted Wed 29 Dec 2010 12:00am Recall Class: Class I Date Recall Initiated: October 11, 2010 Products: Arrow IAB (Intra Aortic Balloon), Ultra 8 Fr, 30cc Arrow IAB (Intra Aortic Balloon), Ultra 8 Fr, 40cc Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System, 30cc Arrow Intra-Aortic Balloon (IAB) ... Read on »
AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I by FDA Posted Wed 05 Jan 2011 11:45am [Posted 01/05/2011] AUDIENCE: Risk Manager, Cardiology ISSUE: The device was recalled because of a design defect causing unintended fracture and peeling, and has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. Use of affected devices may lead to retained device fragments ... Read on »
Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath by FDA Posted Wed 29 Dec 2010 4:00pm [Posted 12/29/2010] AUDIENCE: Risk Manager, Surgery ISSUE: The Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System are recalled because the catheters can become stuck in the sheath. When th ... Read on »
Cook Medical Announces FDA Clearance for Advance® 35LP PTA Balloon Dilatation Catheter - PVD by Medical Quack Patient ExpertHealth Maven Posted Thu 16 Jul 2009 11:05pm Not too long ago I had an extensive interview with the Leg Therapies Division of Cook Medical too, follow the link below for the full story.  Cook Medical Interview Discussing PAD Leg Therapies– Rob Lyles, VP Peripheral Intervention Division “I posed Rob with a scenario, and asked whether I would have the same type of surgery on my leg as m ... Read on »
Brain Catheter Recall from Integra LifeSciences Announced by Medical Quack Patient ExpertHealth Maven Posted Tue 24 Aug 2010 11:44am There are just under 2000 units that were distributed in the US and overseas.  In July customers were notified about the potential defect with the catheter.  This is a class 1 recall, having the most potential harm.  FDA Publishes Information on How to Identify Recalls – Why Not Scan That Stent With A Cell Phone and Make It Easy for the ... Read on »