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U.S. Department of Health and Human Services

Medical Devices

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Abbott Vascular-Cardiac Therapies dba Guidant Corporation, POWERSAIL Coronary Dilatation Catheters

Recall Class: Class I
Date Recall Initiated: June 17, 2009
Product: POWERSAIL Coronary Dilatation Catheters
 
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

These devices were manufactured October 1, 2007 through May 30, 2008.

NOTE: Patients who have already been treated are not affected by this recall.

Use: The POWERSAIL Coronary Dilatation Catheter is used by physicians during medical procedures to dilate heart blood vessels or to dilate implantable stents.
Recalling Firm: Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Road
Temecula, California 92591-4630
Reason for Recall: The distal shaft of the catheter may show damage or tears which may cause a leak of contrast material during use. This could lead to catheter functional failures and medical consequences, including a blocking of a blood vessel caused by air entering the bloodstream (air embolism) and heart attack (myocardial infarction), which has the potential to lead to death.
Public Contact: Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902, seven days a week, twenty-four hours a day.
FDA District: Los Angeles
FDA Comments:

Abbott Vascular sent a recall letter (with a return form) to customers on June 17, 2009. Their sales representatives contacted all customers affected by this recall. The firm instructed the customers to:

  • stop using the devices included in this recall.
  • return the identified devices to the Abbott Vascular Territory Manager.

For more information, please see the firm's press release

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.