Request Legal Help Now - Free
LAWSUITS NEWS & LEGAL INFORMATION

Abbott Issues Recall of POWERSAIL Coronary Dilatation Catheters


Abbott has conducted a voluntary recall of 3 lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of 4 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.

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.

JULY-31-09: Abbott Issues Recall of POWERSAIL Coronary Dilatation Catheters [FDA: ABBOTT RECALLS POWERSAIL CORONARY DILATATION CATHETERS]

Legal Help

If you or a loved one has suffered adverse health effects resulting from exposure to this product, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on Jul-31-09


ADD YOUR COMMENT ON THIS ISSUE

Fields marked * are mandatory. Please read our comment guidelines before posting.

*Name:

Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.
*Your Comment:

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.
Request Legal Help Now! - Free