Class 2 Device Recall Impulse

• Date Initiated by Firm: February 13, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-0729-04
• Recall Event ID: 28447
• Product Classification: Catheter, Intravascular, Diagnostic - Product Code DQO
• Product: Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011
• Code Information: Lot Number 400934
• FEI Number: 3002095335
• Recalling Firm/ Manufacturer: Boston Scientific Scimed; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Anne Marie Reali; 763-494-1408
• Manufacturer Reason for Recall: Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain.
• FDA Determined Cause: Other
• Action: Consignees were sent a recall letter dated February 13, 2004. The letter requested that consignees discontinue use of the recalled catheters and return them.
• Quantity in Commerce: 11 catheters
• Distribution: The product was shipped to consignees in Florida 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.