Class 2 Device Recall Boston Scientific Scimed

• Date Initiated by Firm: August 20, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on October 24, 2005
• Recall Number: Z-0032-04
• Recall Event ID: 27231
• PMA Number: P860019
• Product Classification: Catheters, Transluminal Coronary Angioplasty, Percutaneous - Product Code LOX
• Product: Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151
• Code Information: Lot 5707453
• Recalling Firm/ Manufacturer: Boston Scientific Scimed; One Scimed Place; Maple Grove MN 55311-1566
• For Additional Information Contact: Michelle Gudith; 763-494-1194
• Manufacturer Reason for Recall: Some of the recalled catheters have a component that has levels of pyrogens above specification.
• FDA Determined Cause: Other
• Action: Consignees were sent a recall letter dated August 20, 2003. The letter requested that consignees discontinue use of the catheters from the affected lots and return them.
• Quantity in Commerce: 2 catheters
• Distribution: The recalled products were distributed to consignees located nationwide in the United States.
• 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 = LOX