Class 1 Device Recall POWERSAIL

• Date Initiated by Firm: June 17, 2009
• Date Posted: July 29, 2009
• Recall Status: Terminated on July 06, 2010
• Recall Number: Z-1806-2009
• Recall Event ID: 52705
• PMA Number: P810046
• Product Classification: Coronary Dilatation Catheter - Product Code MAF
• Product: POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US); Part #1005522-18
• Code Information: Lot 8012151(exp 12-2009)
• Recalling Firm/ Manufacturer: Abbott Vascular-Cardiac Therapies dba Guidant Corporation; 26531 Ynez Rd; Temecula CA 92591-4630
• For Additional Information Contact: 951-914-2400
• Manufacturer Reason for Recall: Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
• FDA Determined Cause: Process control
• Action: Abbott Vascular sent an Urgent Device Recall letter (w/return form) to customers on June 17, 2009 requesting return of identified products to Abbott Vascular Territory Manager. Abbott Vascular issued a press release dated July 28, 2009.
• Quantity in Commerce: 557 total devices
• Distribution: Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MAF and Original Applicant = ADVANCED CARDIOVASCULAR SYSTEMS, INC.