• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Cretex Companies CEO Steps Down

    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

    Endoscopic Hemostasis Devices Market Valued at $730 Million

    Henry Schein Buys Majority Interest in Prism Medical Products

    Boston Scientific's Vercise Genus DBS Earns FDA Approval
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    maxon

    Concise Engineering

    Medbio LLC

    Creganna Medical, part of TE Connectivity

    Medicoil
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Element

    Spectrum Plastics Group

    Medicoil

    MW Life Sciences

    PTI Engineered Plastics Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Cook Recalls PTA Balloon Catheters Due to Balloons Bursting

    Multiple complaints were received for balloons in Cook's Advance Enforcer 35 Focal Force PTA Balloon Catheter bursting below the rated burst pressure.

    U.S. Food and Drug Administration06.19.19
    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
     
    Recalled Product: Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm
     
    Model Numbers:
     
    • 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248
    • 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252
    • 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257
    • Lot Numbers: 9234424, 9331618, 9212015, 9243035, 9320430, 9386804, 9338194, 9234423, 9278982, 9209468, 9248603, 9320429
     
    Manufacturing Dates: October 3, 2018 to December 17, 2018.
    Distribution Dates: October 29, 2018 to March 21, 2019.
    Devices Recalled in the U.S.: 33
    Date Initiated by Firm: May 24, 2019
     
    The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is used by healthcare providers for opening blocked or narrowed arteries that supply blood to the leg (percutaneous transluminal angioplasty (PTA)). This catheter is not for use in the brain or heart. 
     
    Multiple complaints were received for balloons bursting below the rated burst pressure. While there were no reports of malfunctions, deaths, or injury reported for this balloon issue, there is a high occurrence rate. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, balloon fragmentation in the patient, and death.
     
    Healthcare professionals using the Advance Enforcer 35 Focal-Force PTA Balloon Catheter and patients undergoing procedures involving the device may be affected.
     
    On May 24, 2019, Cook Medical, the customer relations department of Cook Inc., sent an Urgent Medical Device Recall notification letter to customers.  The letter asked customers to:
     
    • Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products.
    • Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited.
    • Please complete the Acknowledgement and Receipt Form within 5 business days. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or by email to FieldActionsNA@CookMedical.com. If you have a product to return, contact Stericycle at phone number 855-205-2627 to obtain a credit and reference event number 10082.
    • Share the notification letter with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred.
    • Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com.
    Related Searches
    • contact
    • pta balloon catheters
    • catheter
    • blood
    Related Knowledge Center
    • Cardiovascular
    • Surgical

    Related Breaking News

    • Cardiovascular
      First Heart Failure Patient Treated With Impulse Dynamics

      First Heart Failure Patient Treated With Impulse Dynamics' CCM Therapy in Brazil

      The Optimizer delivers cardiac contractility modulation therapy, the company’s proprietary technology, to the heart.
      Business Wire 01.21.21

    • Cardiovascular
      Boston Scientific to Acquire Preventice for Up to $925M

      Boston Scientific to Acquire Preventice for Up to $925M

      Acquisition of external cardiac monitoring technologies, services provider to expand rhythm management diagnostics portfolio.
      PR Newswire 01.21.21

    • Cardiovascular | Surgical
      Haemonetics to Acquire Cardiva for Up to $510M

      Haemonetics to Acquire Cardiva for Up to $510M

      Enhances penetration into the large and growing interventional cardiology and electrophysiology markets.
      PR Newswire 01.20.21


    • Cardiovascular | Surgical
      Abbott Wins Expanded Medicare Coverage for MitraClip

      Abbott Wins Expanded Medicare Coverage for MitraClip

      Includes patients with secondary (or functional) mitral regurgitation resulting from heart failure.
      Abbott Laboratories 01.20.21

    • Surgical
      Freehand Partners with Imperial Medical Solutions

      Freehand Partners with Imperial Medical Solutions

      Supports the introduction of its surgical robots in India, Sri Lanka, Malaysia and the Caribbean.
      Freehand 01.19.21

    • Cardiovascular | Patient Monitoring
      Hillrom to Buy Bardy Diagnostics for $375M

      Hillrom to Buy Bardy Diagnostics for $375M

      Advances digital health offering with expansion into attractive ambulatory cardiac monitoring segment.
      PR Newswire 01.19.21


    • Cardiovascular
      Occlutech

      Occlutech's Atrial Flow Regulator Earns Breakthrough Status for HF

      First-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients.
      PR Newswire 01.19.21

    • Cardiovascular | Diagnostics
      FDA OKs MRI for Impulse Dynamics

      FDA OKs MRI for Impulse Dynamics' Optimizer CCM Delivery Systems

      FDA clears potential hurdle for many heart failure patients.
      Business Wire 01.19.21

    • Surgical
      TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

      TransEnterix Wins EU Approval for Robotic Surgical Machine Vision System

      Intelligent Surgical Unit enables augmented intelligence on the Senhance surgical system.
      Business Wire 01.19.21


    • Cardiovascular
      FineHeart Successfully Tests Wireless TET System

      FineHeart Successfully Tests Wireless TET System

      A breakthrough in treating patients with severe heart failure.
      FineHeart 01.18.21

    • Cardiovascular
      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.
      GlobalData 01.15.21

    • Surgical
      Moon Surgical Expands Leadership Team

      Moon Surgical Expands Leadership Team

      Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.
      Moon Surgical 01.14.21


    • Cardiovascular
      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      WhiteSwell Issued Patent for Treatment of Acute Decompensated Heart Failure

      Company adds to portfolio of 40 patents for catheter-based technology that leverages the power of the body’s natural fluid removal process.
      Business Wire 01.13.21

    • Neurological | Surgical
      FDA OKs ClearMind Biomedical

      FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

      Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.
      PR Newswire 01.12.21

    • Cardiovascular
      Acutus Medical Launches AcQCross Transseptal System in Europe

      Acutus Medical Launches AcQCross Transseptal System in Europe

      The product is designed to improve safety and efficiency in any procedure requiring left heart access.
      Globe Newswire 01.08.21


    Trending
    • Telemedicine, Regulatory Changes To Characterize Medtech Industry In 2021
    • Masimo Earns CE Mark For New Fingertip Pulse Oximeter
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Philips Buys Capsule Technologies In $635M Deal
    • Understanding Food-Grade Vs. Biocompatibility For Medical Device Materials
    Breaking News
    • Cretex Companies CEO Steps Down
    • Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    • Endoscopic Hemostasis Devices Market Valued at $730 Million
    • Henry Schein Buys Majority Interest in Prism Medical Products
    • Boston Scientific's Vercise Genus DBS Earns FDA Approval
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    NIH Study Compares Low-Fat, Plant-based to Low-Carb, Animal-Based Diet
    Gadot Positions Mineral Line for Vegan Market
    Nutritfy India to Launch Global Broadcast Channel Covering Nutrition
    Coatings World

    Latest Breaking News From Coatings World

    LINE-X Launches Dealer Program with International Truck
    PPG Reports Q4, Full-year 2020 Financial Results
    BASF Begins Implementing Ralignment of Global Business Services Unit
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cretex Companies CEO Steps Down
    Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread
    Endoscopic Hemostasis Devices Market Valued at $730 Million
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Pfizer, BioNTech Enter Vax Pact with COVAX
    FDA Approves Janssen’s CABENUVA
    AGC Biologics Appoints Boulder Site GM
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Coty Appoints Chief Procurement Officer
    Lageen Tubes Launches Mono-Material PE Tube Solutions
    Jason Jones Loses Battle with Covid-19
    Happi

    Latest Breaking News From Happi

    Carol’s Daughter Adds New Hair Products
    Moroccan Gold Series Launches NuDo Shampoo
    Youbody Debuts Waterless Body Wash
    Ink World

    Latest Breaking News From Ink World

    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    AR Packaging Acquiring Firstan Holdings Ltd
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Gallus planning virtual event for March
    Lemu Group engineers mask-making machine
    Niagara Label upgrades with Nilpeter flexo press
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Lemu Group Engineers Mask-Making Machine
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Sectra, RSA Biomedical Sign Distribution Agreement for Implant Stability Tool
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    UDC Subsidiary Adesis' Website Wins 2020 MarCom Platinum Award
    Ambiq Wins IoT Semiconductor Company of the Year Award
    Ynvisible Names Michael Robinson CEO, Jani-Mikael Kuusisto SVP Ventures

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login