News | September 10, 2010

AngioScore Recalls Scoring Balloon Catheter

September 10, 2010 – Cath Labs are being encouraged this week by the U.S. Food and Drug Administration (FDA) to inspect their inventories for AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheters. Devices manufactured between Jan. 30 and Dec. 4, 2009 are part of a class 1 product recall due to safety concerns.

The FDA said the catheters may become separated during use, in which fragments of the catheter may become lodged in coronary arteries. This may result in serious injuries, including death. The recall only includes the EX catheters.

The recall was originally initiated on Dec. 4, 2009, but the FDA reissued the alert this week. The affected catheters include all part/REF numbers 2034-XXYY with lot numbers less than F09060003.

The AngioSculpt PTCA Scoring Balloon Catheter is used to dilate narrowed coronary arteries and to improve myocardial perfusion.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

For more information: www.fda.gov

Related Content

News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
Spectranetics Announces FDA Approval of Stellarex Drug-Coated Balloon
Technology | Drug-Eluting Balloons| July 26, 2017
The Spectranetics Corp. announced receipt of U.S. Food and Drug Administration (FDA) pre-market approval (PMA) of the...
News | June 12, 2017
June 12, 2017 – Med Alliance announced completion on schedule of patient enrollment in the first-in-man (FIM) study o
Abbott recalls its NC Balloon catheters
News | Balloon Catheter| May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Sponsored Content | Videos | EP Lab| May 17, 2017
This video, provided by Spectranetics, demonstrates how to deploy the Bridge Occlusion Balloon used to seal accidenta
Contego Medical Receives CE Mark for Vanguard IEP Peripheral Balloon Angioplasty System
News | Peripheral Artery Disease (PAD)| May 17, 2017
Contego Medical LLC announced recently that it has received CE Marking of its Vanguard IEP Peripheral Balloon...
Twelve-Month Data Positive for Ranger Paclitaxel-Coated Balloon Catheter
News | Drug-Eluting Balloons| April 26, 2017
Boston Scientific announced results from the RANGER SFA trial for the Ranger Paclitaxel-Coated PTA Balloon Catheter at...
Medtronic, IN.PACT Admiral DCB, drug-coated balloon, below-the-knee, European BTK IN.PACT clinical study, peripheral artery disease, PAD, launch
News | Peripheral Artery Disease (PAD)| March 09, 2017
Medtronic plc announced the launch of the IN.PACT BTK study to evaluate the effectiveness of a drug-coated balloon (DCB...
Medtronic, IDE approval, IN.PACT Admiral drug-coated balloon, DCB, end-stage renal disease
News | Drug-Eluting Balloons| February 08, 2017
Medtronic plc announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug Administration...
Spectranetics, Stellarex 0.014-inch DCB, CE Mark
News | Drug-Eluting Balloons| December 06, 2016
December 6, 2016 — The Spectranetics Corp.
Overlay Init