Wednesday, September 09 2009
Guidant POWERSAIL Coronary Dilatation Catheter Recall Due to Failures
Abbott and FDA notified healthcare professionals of the national Class 1 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 that the distal shaft of the catheter exhibited damage. The damage 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.
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 Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
Guidant POWERSAIL Coronary Dilatation Catheter Lawsuit - Talk to a Lawyer
If you or a loved one have suffered a serious injury or death as a result of the use or misuse of the above product, then please call us for a Free Confidential Case Consultation. Talk to a Board Certified Personal Injury Trial Lawyer with more than 25+ years of experience call 1-800-883-9858