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...]

      UPDATE – Sandoz Inc. Issues Voluntary Nationwide Recall Expansion of One Additional Lot of Cefazolin for Injection Due to Product Mislabeling

      Summary Company Announcement Date: July 14, 2025 FDA Publish Date: July … [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 / Abbott Issues Voluntary Recall of POWERSAIL Coronary Dilatation Catheters

Abbott Issues Voluntary Recall of POWERSAIL Coronary Dilatation Catheters

July 31, 2009 By The FDA Leave a Comment

Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Abbott Vascular’s sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the part numbers and lot numbers listed below. All outstanding units are in the company’s possession or are in transit. Patients who have already been treated are not affected by this action.

POWERSAIL® 3.25x18mm (U.S.)

POWERSAIL® 4.0x8mm (CE)

POWERSAIL® 2.75x18mm (U.S.)

POWERSAIL® 3.25x8mm (U.S.)

Three out of the four complaints of distal shaft damage resulted in no adverse patient effects. One complaint reported that the patient had evidence of a post-procedural myocardial infarction. Subsequently, the patient was reported to be doing well.

The United States Food and Drug Administration (FDA) has been apprised of this action, and it has classified this action as a Class I recall.

The POWERSAIL Coronary Dilatation Catheter is distributed for prescription use only to approved U.S. and international health care organizations. Affected devices can be identified by the part number and lot number combinations shown above.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.

Any adverse reactions experienced with the use of this product, and/or quality problems should 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: 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 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

UPDATE – Sandoz Inc. Issues Voluntary Nationwide Recall Expansion of One Additional Lot of Cefazolin for Injection Due to Product Mislabeling

July 14, 2025 By The FDA

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

July 11, 2025 By The FDA

LLK Trading Inc. Recalls “Needle Mushrooms” Because of Possible Health Risk

July 10, 2025 By The FDA

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards

July 9, 2025 By The CPSC

WLIVE Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon by WLIVE

July 9, 2025 By The CPSC

Giant Bicycle Recalls Momentum Vida E+ E-Bikes Due to Crash Hazard

July 9, 2025 By The CPSC

SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology

July 9, 2025 By The CPSC

AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA

July 9, 2025 By The CPSC

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology

July 9, 2025 By The CPSC

AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA

July 9, 2025 By The CPSC

Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm

July 9, 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

  • UPDATE – Sandoz Inc. Issues Voluntary Nationwide Recall Expansion of One Additional Lot of Cefazolin for Injection Due to Product Mislabeling
  • Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry
  • LLK Trading Inc. Recalls “Needle Mushrooms” Because of Possible Health Risk
  • Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
  • Wiet Peeters Farm Products Limited RECALLS “Aunt Mid’s Fresh Sliced Mushrooms, Peeters Mushroom Farm Cremini Sliced and Peeters Mushroom Farm Thick Slice Mushroom ” Because of Possible Listeria Monocytogenes Contamination
  • Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards
  • WLIVE Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon by WLIVE
  • Giant Bicycle Recalls Momentum Vida E+ E-Bikes Due to Crash Hazard
  • SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology
-- 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