US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Daiso Issues Alergy Alert for Prepackaged Snacks

      Summary Company Announcement Date: February 03, 2023 FDA Publish Date: … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Oscor Inc. Issues Nationwide Recall of ATAR Extension Cables

Oscor Inc. Issues Nationwide Recall of ATAR Extension Cables

July 6, 2017 By The FDA Leave a Comment

INTENDED USE: The extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

DEVICE DESCRIPTION: The ATAR cable is an extension cable with connector(s) on both sides, designed to connect with various receptacles or cables/leads, depending on the instrument being used.

REASON FOR THE VOLUNTARY PRODUCT REMOVAL:

During the use of some ATAR extension cables, the cable was separating from the connector at the proximal end. The analysis of the returned devices revealed a change in the manufacturing sequence attributed to the connector and wire separation, causing a fracture of the conductor cable from extensive use.  This event resulted in cable malfunction, causing interruption of the pacing system.  Oscor received a total of 66 complaints related to that failure mode, of which 5 resulted in patient injuries.  No deaths were reported; however the risk for possible injury is a concern if the cable separates during use. 
 
WARNING:

For pacing dependent patients, an interruption of pacing system could result in serious injury or death if not detected. Continuous monitoring is required.

ATAR EXTENSION CABLE – REUSABLE MODELS:

ATAR-53912 & 53912A ATAR-T2 ATAR-R X2 ATAR-MDTL
ATAR-MDT2S-V ATAR-R ATAR-MDT2 ATAR-T
ATAR A ATAR-RL ATAR-V2 ATAR-R T4P
ATAR-V ATAR MDT3 ATAR-R NP ATAR-MDTR
ATAR-AT ATAR-R1 XI.DR XI.DV
ATAR-MDTS ATAR-R D2P XI.DMDT XI.DA
ATAR-MDT ATAR-R T2P XI.DT  

 ATAR EXTENSION CABLE – DISPOSABLE MODELS:

ATAR-53912D ATAR D-T2 ATAR D-R X2 ATAR D-MDTL
ATAR D-MDT2S-V ATAR D-R ATAR D-MDT2 ATAR D-T
ATAR D-A ATAR D-RL ATAR D-V2 ATAR D-R T4P
ATAR D-V ATAR DMDT3 ATAR D-R NP ATAR D-MDTR
ATAR-D-AT ATAR D-R1 XI. DR XI.V
ATAR D-MDTS ATAR D-R D2P XI.MDT XI.A
ATAR D-MDT ATAR D-R T2P XI.T  

Customer may contact Oscor’s Customer Service Group, Monday to Friday from 8:30AM to 6:00PM Eastern Time at 727-937-2511 or via email at [email protected].

Healthcare professionals are encouraged to report any malfunction and/or adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to    the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
 

###

Share this:

  • Facebook
  • Twitter
  • LinkedIn
  • Email
  • Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a Reply Cancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Daiso Issues Alergy Alert for Prepackaged Snacks

February 3, 2023 By The FDA

Fresh Ideation Food Group LLC Recalls Sandwiches and Other Products Because of Possible Health Risk

February 3, 2023 By The FDA

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination

February 2, 2023 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by BTPEIHTD; Sold Exclusively at Amazon.com

February 1, 2023 By The CPSC

Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by ChildLikeMe; Sold Exclusively at Amazon.com

February 1, 2023 By The CPSC

Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by SGMWVB Brand; Sold Exclusively on Amazon.com

February 1, 2023 By The CPSC

Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk

February 1, 2023 By The FDA

B&G Foods Issues Voluntary Allergy Alert for Undeclared Peanut in Three Cases of Back to Nature® Fudge Mint Cookies

January 31, 2023 By The FDA

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk

February 1, 2023 By The FDA

B&G Foods Issues Voluntary Allergy Alert for Undeclared Peanut in Three Cases of Back to Nature® Fudge Mint Cookies

January 31, 2023 By The FDA

IBSA Pharma Inc. Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

January 30, 2023 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Daiso Issues Alergy Alert for Prepackaged Snacks
  • Fresh Ideation Food Group LLC Recalls Sandwiches and Other Products Because of Possible Health Risk
  • Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination
  • Paper Cape Recalls Children’s Pajamas Due to Violation of Federal Flammability Standards and Burn Hazard
  • Children’s Robes Recalled Due to Violation of Federal Flammability Standard and Burn Hazard; Imported by Betusline Official Apparel; Sold Exclusively on Amazon.com
  • Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by BTPEIHTD; Sold Exclusively at Amazon.com
  • Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by ChildLikeMe; Sold Exclusively at Amazon.com
  • Children’s Robes Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by SGMWVB Brand; Sold Exclusively on Amazon.com
  • Shop Me Ca Recalls “Diep Bao Cream” Because of Possible Health Risk
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2023 Altrumedia · Terms of Service · Log in