Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall RunWay

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall RunWaysee related information
Date Initiated by FirmOctober 29, 2004
Date PostedJanuary 28, 2005
Recall Status1 Terminated 3 on November 10, 2006
Recall NumberZ-0454-05
Recall Event ID 30405
510(K)NumberK033441 
Product Classification Catheter, Percutaneous - Product Code DQY
ProductRunWay 6F Cardiovascular Guide Catheter.
Code Information all models and lot numbers of the Boston Scientific RunWay 6F Guide Catheter.
Recalling Firm/
Manufacturer		 Boston Scientific Scimed
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactPaul Donovan
508-667-5165
Manufacturer Reason
for Recall		The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon
FDA Determined
Cause 2		Other
ActionOn 10/29/04 the Boston Scientific Sales force was notified via voice mail of the recall. Sales personnel were told to contact their accounts/customers by the end of the business day on 11/02/04. Accounts/customers were to receive written notice of the recall via Fed Ex on Monday 11/01/04. Sales Personnel are to ensure that accounts/customers got notice of the recall, understand instructions and are taking appropriate steps. Catheters are to be returned to Boston Scientific Corporation, Quincy, MA.
Quantity in Commerce76,984
DistributionThroughout United States and into 15 other countries.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = DQY
-
-