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...]

      509 Recalls Helmets Due to Risk of Head Injury

      The recalled helmets fail to provide sufficient protection in the event of a crash, posing a risk of head injury. … [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 / Drug Recalls / Arrow International Announces Worldwide Voluntary Recall of Intra Aortic Balloon Pump (IAB) Catheters

Arrow International Announces Worldwide Voluntary Recall of Intra Aortic Balloon Pump (IAB) Catheters

April 17, 2009 By The FDA Leave a Comment

TELEFLEX MEDICAL ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS CLASSIFIED THE VOLUNTARY MEDICAL DEVICE RECALL INITIATED ON FEBRUARY 2, 2009 BY ARROW INTERNATIONAL’S CARDIAC CARE DIVISION INVOLVING VOLUME CONNECTORS FOR ITS 30CC, 40CC AND 50CC INTRA AORTIC BALLOON PUMP (IAB) CATHETERS AS A CLASS 1 RECALL. FDA DEFINES CLASS I RECALLS AS, “A SITUATION IN WHICH THERE IS A REASONABLE PROBABILITY THAT THE USE OF OR EXPOSURE TO A VIOLATIVE PRODUCT WILL CAUSE SERIOUS ADVERSE HEALTH CONSEQUENCES OR DEATH.” THIS RECALL IS BEING CONDUCTED BECAUSE A FAULT IN THE CONNECTOR OF THE PUMP TUBING ASSEMBLY MAY RESULT IN THE VOLUME SETTING ON THE PUMP DEFAULTING TO 2.5 CC OR 5 CC, RATHER THAN THE APPROPRIATE 30, 40, OR 50 CC VOLUME. IN PATIENTS EXHIBITING MODERATE TO SEVERE MYOCARDIAL ISCHEMIA OR LOW PERFUSION STATES, PROLONGED EXPOSURE TO THE LOW DEFAULT VOLUME MAY FAIL TO DECREASE ISCHEMIA AND INCREASE PERFUSION, LEADING TO ORGAN INJURY OR INFARCT AND MAY RESULT IN PATIENT DEATH. PROLONGED EXPOSURE TO A DEVICE WHICH IS INFLATED TO LESS THAN 2/3 FULL COULD ALSO RESULT IN THROMBUS FORMATION ON THE IAB AND POSSIBLE SUBSEQUENT SYSTEMIC OR CEREBRAL THROMBOEMBOLISM. INSTRUCTIONS CONTAINED IN THE OPERATOR’S MANUAL FULLY DESCRIBE THE NECESSARY WARNINGS AND PRECAUTIONS THAT WILL IDENTIFY THE ISSUE. THE RECALL NOTICE RESTATES THESE INSTRUCTIONS AND REFERENCES THE SECTIONS IN THE OWNER’S MANUAL. IF THESE INSTRUCTIONS ARE FOLLOWED, THE ISSUE FOR WHICH THE PRODUCT WAS RECALLED CAN BE DISCOVERED IMMEDIATELY, AND THE PRODUCT CAN BE REMOVED AND REPLACED. ARROW INTERNATIONAL NOTIFIED BOTH DOMESTIC AND FOREIGN HOSPITALS AND DISTRIBUTORS VIA AN URGENT MEDICAL DEVICE RECALL LETTER DATED FEBRUARY 2, 2009 THAT THE COMPANY HAD BECOME AWARE THAT THE BLUE CONNECTOR FOR THE 40CC IAB WAS NOT PROPERLY RECOGNIZED BY THE ARROW INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM. THIS RECALL INVOLVED THE RETRIEVAL OF UNUSED PRODUCT, ISSUANCE OF MITIGATION INSTRUCTIONS FOR PATIENTS AND/OR FACILITIES IN CRITICAL NEED, AND THE REPLACEMENT OF PUMP TUBING ASSEMBLIES. AT THIS TIME, THERE HAVE BEEN 25 COMPLAINTS OF THIS ISSUE. THERE HAVE BEEN NO REPORTS OF PATIENT INJURY AS A RESULT OF THIS ISSUE. APPROX. 423 LOTS ARE AFFECTED BY THIS RECALL FOR A TOTAL 45,211 UNITS.

PRODUCTS AFFECTED: 30/40/50 CC IAB CATHETERS: PRODUCT CODES: IAB-04830-U, IAB-04840-U, IAB-05830-LWS, IAB05830-U, IAB-05840-U, IAB-05840-LWS, IAB06830-U, IAB06840-U, IAB-S730C, IAB-S840C, IAB-R950-U, IAK-02692, IAK-02693, AND IAK-02691. A LIST OF PRODUCTS AND LOT NUMBERS AFFECTED BY THIS RECALL AS WELL AS THE ORIGINAL RECALL NOTICE CAN BE FOUND AT ARROW’S WEBSITE: HTTP://WWW.ARROWINTL.COM/IAB_RECALL.ASP CONSUMERS WITH QUESTIONS MAY CONTACT THE COMPANY AT 1-800-523-8446; 8AM TO 8PM, ET, MONDAY THROUGH FRIDAY, FOR INTERNATIONAL CALLS 001-919-361-4062; 8AM TO 5PM, ET, MONDAY THROUGH FRIDAY. ANY ADVERSE REACTIONS EXPERIENCED WITH THE USE OF THIS PRODUCT, AND/OR QUALITY PROBLEMS CAN ALSO BE REPORTED TO THE FDA’S MEDWATCH PROGRAM BY PHONE AT 1-800-FDA-1088, BY FAX AT 1-800-FDA-0178, BY MAIL AT MEDWATCH, HF-2, FDA, 5600 FISHERS LANE, ROCKVILLE, MD 20852-9787, OR ON THE MEDWATCH WEBSITE AT WWW.FDA.GOV/MEDWATCH

 

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: Drug Recalls

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 ReplyCancel 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

509 Recalls Helmets Due to Risk of Head Injury

July 2, 2025 By The CPSC

SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi

July 2, 2025 By The CPSC

Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard

July 2, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop

July 2, 2025 By The CPSC

Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard

July 2, 2025 By The CPSC

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

June 27, 2025 By The FDA

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu

June 25, 2025 By The FDA

The Coleman Company Recalls Converta Camping Cots and Converta Camping Suspension Stretchers Due to Laceration and Amputation Hazards; Imported by Newell Brands

June 25, 2025 By The CPSC

iHerb Recalls Bottles and Blister Packs of California Gold Nutrition Iron Supplements Due to Risk of Serious Injury or Death from Child Poisoning; Violation of Federal Standard for Child Resistant Packaging

June 25, 2025 By The CPSC

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

  • 509 Recalls Helmets Due to Risk of Head Injury
  • SNLN Party Supply Toys Recalled Due to Ingestion Hazard; Risk of Serious Injury or Death; Federal Toy Standard Violation; Sold Exclusively on Amazon by Yiwu Dixikeji Douxiangongsi
  • Harbor Freight Tools Recalls Predator 2000-Watt Power Stations Due to Shock Hazard
  • DEWALT Recalls Grinder Flap Discs Due to Laceration and Injury Hazards
  • Trane Recalls Gas/Electric Packaged Units Due to Risk of Gas Leak, Fire Hazard
  • Jeriflyer Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violation of the Virginia Graeme Baker Pool and Spa Safety Act; Sold on Amazon by Junjuanshop
  • Positec Recalls Electric Corded Chainsaws and Pole Saws Due to Laceration Hazard
  • Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
  • Shang Hao Jia, Inc. Issues Allergy Alert on Undeclared Sesame in Danshi Brand Spicy Shredded Tofu
-- 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 © 2025 Altrumedia · Terms of Service · Log in