• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Turbo Elite Atherectomy Catheter

  • 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 Turbo Elite Atherectomy Catheter see related information
Date Initiated by Firm October 31, 2016
Date Posted November 28, 2016
Recall Status1 Terminated 3 on April 18, 2017
Recall Number Z-0661-2017
Recall Event ID 75617
510(K)Number K140775  
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
Product Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01
The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.
Code Information FBD16D01A; FBD16F20A; FBD16D11A; FBD16F29A; FBD16D14A; FBD16G18A; FBD16D23A; FBD16G29A; FBD16E05A; FBD16H03A; FBD16E11A; FBD16H26A FBD16E19A; FBD16J06A; FBD16E26A; FBD16J21A; FBD16F03A; FBD16J26A; FBE16C30A; FBE16H24A; FBE16E25A; FBE16J14A; FBE16F15A; FAY16C29A; FAY16G14A; FAY16D08A; FAY16G29A; FAY16D26A; FAY16H23A; FAY16E17A; FAY16H31A; FAY16F08A; FAY16J23B; FAY16G01A; FBF16D27A; FBF16G07A FBF16E12A ; FBF16H10B; FBF16F17A; FBF16J16A; FAZ16C31A; FAZ16G25A; FAZ16D14A ; FAZ16H01A; FAZ16D25A; FAZ16H22A; FAZ16E06A; FAZ16H30A FAZ16F24B; FAZ16J20A; FAZ16F27A; FBG16E02A; FBG16H31A; FBG16F23A; CBA16H19A; FBA16F27A; CBA16H19B; FBA16G11A; CBA16H19C; FBA16G15A; FBA16D04A; FBA16G19A; FBA16D06A; FBA16G27B; FBA16D18A; FBA16H02A FBA16D21A; FBA16H08A; FBA16E09A; FBA16H17A; FBA16E10A; FBA16J02A FBA16E13A; FBA16J07A; FBA16E19A; FBA16J19A; FBA16F07A; FBA16J22A; FBA16F21A; FBE16E02A; FBE16G06A; FBE16G20A; FAZ16E26A; FAZ16G12A; FBA16D29A; FBA16F16B;
Recalling Firm/
Spectranetics Corporation
9965 Federal Drive
Colorado Springs CO 80921-3617
For Additional Information Contact Lindsay K Pack
Manufacturer Reason
for Recall
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
FDA Determined
Cause 2
Action Spectranectics sent an Urgent Medical Device Recall letter dated October 31, 2016, to all affected consignees. Consignees were instructed to discontinue use of the potentially impacted lots and return the product for replacement. Consignees were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return of any remaining product in inventory. Customers with questions were instructed to call 1-800-231-0978, Option 2. For questions regarding this recall call 719-651-8517.
Quantity in Commerce 14,624 units
Distribution Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.
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.
510(K) Database 510(K)s with Product Code = MCW and Original Applicant = SPECTRANETICS CORPORATION