SEARCH
Current Location:
>
> This Story


Log in or Register to rate this News Story
Forward Printable StoryPrint Comment

Never Miss a Story

Sign up for email alerts

 

More Industry Headlines

Charles Townes, laser pioneer, passes away at age 99 Remembering the Nobel Prize-winning physicist

Siemens names Bernd Montag as new CEO of health care Current CEO, Hermann Requardt will step down as of Feb. 1

MedInformatix partners with Vestrum Health to make EHRs profitable for physicians Trying to pay off that new EHR system? Sell the anonymous data

AdvaMed survey details the negative impact of the medical device tax A look at the effect two years later

Introducing the American Board of MR Safety Group aims to address rising incidence of MR accidents

HHS sets goals to move from volume- to value-based Medicare payments Will it link 85 percent of payments to quality by 2016 and 90 percent by 2018?

More experienced PCPs see greater benefits in advanced imaging than less experienced counterparts Why are older PCPs greater advocates for CT, MR, and PET than newer ones?

Bad air quality is good for sleep apnea device market Sleep apnea is fastest growing segment in respirator market

EOS imaging scores FDA approval for X-ray Micro Dose feature Helps hospitals attain As Low As Reasonably Achievable radiation dose

Head CT scan for patients suffering dizziness is over-utilized Research says only 7.1 percent yield benefits

FDA deems Boston Scientific imaging catheter recall Class 1

by Brendon Nafziger , DOTmed News Associate Editor
The Food and Drug Administration said Tuesday a recall of more than 110,000 Boston Scientific imaging catheters used with intravascular ultrasound systems was deemed Class 1, its most serious.

The recall, announced last month, applies to the iCross 40 Mhz Coronary Imaging Catheter, sold in the United States and its territories, and the Atlantis SR Pro2 version, distributed internationally, the FDA said. The devices are used to check for pathologies inside the coronary arteries for patients who are candidates for angioplasties.

Story Continues Below Advertisement

Training(UnisonMed Academy) & Parts(Medical Essence) for Siemens & Philips

***UnisonMed Academy: Training Specialist for Siemens & Philips System (www.unisonmedacademy.com) *** Medical Essence: Parts Provider for Siemens & Philips System (www.medicalessence.com)



The FDA said the catheter tip can snap inside the patient, causing tissue and blood vessel injury, or even a heart attack.

The Natick, Mass.-based device company first announced a voluntary recall of the products in a May 27 letter to customers. At the time, the recall was said to affect 29,664 units.

In its notice, Boston Scientific said it had confirmed eight cases of catheter tip detachments in the United States and Puerto Rico due to "embrittlement" between April 1, 2010 and May 10, 2011. Based on market data, this translates to a break rate of 0.027 percent, the company said.

"To date, the majority of confirmed brittle tip detachments have been successfully retrieved (typically snared percutaneously)," the company said in a statement. "Because the potential for tip detachment is undetectable prior to use, modifications to the IVUS procedure will have little impact on the likelihood of occurrence of these events."

Boston Scientific said it would replace affected catheters free of charge.

Class 1 recalls mean there's a reasonable probability that use of the product could result in serious injury or death, the FDA said. Adverse events should be reported to the FDA's Medwatch Program by phone at 1-800-FDA-1088 or on its website, www.fda.gov/medwatch.

Related:


Interested in Medical Industry News? Subscribe to DOTmed's weekly news email and always be informed. Click here, it takes just 30 seconds.

You Must Be Logged In To Post A Comment

Advertise
Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Directory
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Requests
Gold Service Dealer Program
Receive RFP/PS
Requests
Healthcare Providers
See all
HCP Tools
Jobs/Training
Find/Fill
A Job
Parts Hunter +EasyPay
Get Parts
Quotes
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Center
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Quotes
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2015 DOTmed.com, Inc.
ALL RIGHTS RESERVED