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 Boston Scientific Scimed

  • 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 Boston Scientific Scimedsee related information
Date Initiated by FirmJuly 01, 2003
Date PostedAugust 12, 2003
Recall Status1 Terminated 3 on December 28, 2006
Recall NumberZ-1112-03
Recall Event ID 26708
510(K)NumberK021735 
Product Classification unknown device name - Product Code GBR
ProductUltra-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 ContactPatrick Burt
763-494-1192
Manufacturer Reason
for Recall		Some of the product pouches have holes in the seals.
FDA Determined
Cause 2		Other
ActionConsignees 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 Commerce17
DistributionThe 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) Database510(K)s with Product Code = GBR
-
-