Class 2 Device Recall Boston Scientific Scimed

• Date Initiated by Firm: July 01, 2003
• Date Posted: August 12, 2003
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-1112-03
• Recall Event ID: 26708
• 510(K)Number: K021735
• Product Classification: unknown device name - Product Code GBR
• Product: Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-7020
• Code Information: Lot numbers 5463705 and 5464511
• Recalling Firm/ Manufacturer: Boston Scientific Scimed; One Scimed Place; Maple Grove MN 55311-1566
• For Additional Information Contact: Patrick Burt; 763-494-1192
• Manufacturer Reason for Recall: Some of the product pouches have holes in the seals.
• FDA Determined Cause: Other
• Action: Consignees were sent a recall letter dated July 1, 2003. The letter requested that consignees discontinue use of the recalled catheters and return them.
• Quantity in Commerce: 17
• Distribution: The recalled products were shipped to hospitals located nationwide in the United States.

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.

• 510(K) Database: 510(K)s with Product Code = GBR and Original Applicant = BOSTON SCIENTIFIC SCIMED, INC.