FDA MedWatch - Coronary Dilatation Catheters

POWERSAIL Coronary Dilatation Catheters
Audience: Cardiovascular surgery healthcare professionals, hospital risk managers, surgical service supervisory staff

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].

Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm174608.htm

POWERSAIL Coronary Dilatation Catheters
Audience: Cardiovascular surgery healthcare professionals, hospital risk managers, surgical service supervisory staff

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].

[07/30/2009 - Press Release - Abbott]

Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Abbott Issues Voluntary Recall of POWERSAIL® Coronary Dilatation Catheters

Media:
Jonathon Hamilton
(408) 845-3491

Financial:
Tina Ventura
(847) 935-9390

FOR IMMEDIATE RELEASE - ABBOTT PARK, Ill. - July 28, 2009 - 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.

Product Designation Product Number Lot
Number Expiration Date
POWERSAIL® 3.25x18mm (U.S.) 1005524-18
7101051
09-2009

POWERSAIL® 4.0x8mm (CE) 1005726-08
7112051
10-2009

POWERSAIL® 2.75x18mm (U.S.) 1005522-18
8012151
12-2009

POWERSAIL® 3.25x8mm (U.S.) 1005524-08
8053061
04-2010

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.