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 Spectranetics TurboElite Laser Atherectomy Catheters

  • 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 Spectranetics TurboElite Laser Atherectomy Catheters see related information
Date Initiated by Firm June 06, 2017
Date Posted July 14, 2017
Recall Status1 Terminated 3 on July 08, 2021
Recall Number Z-2863-2017
Recall Event ID 77474
510(K)Number K170059  
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
Product Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters
Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
Code Information Model Number 414-159 Catheter Diameter 1.4mm,  Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm.
Recalling Firm/
Manufacturer		 Spectranetics Corporation
9965 Federal Drive
Colorado Springs CO 80921-3617
For Additional Information Contact Customer Service
800-231-0978 Ext. 2
Manufacturer Reason
for Recall		 Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
FDA Determined
Cause 2		 Device Design
Action Spectranetics sent a Field Safety Notice letter via certified mail on June 7, 2017, to all customers who have ordered the affected model numbers since 23May2016 reiterating the risks associated with off-label use of the device (i.e., not activating the laser within a stent and not until all contrast media is flushed from the treatment area). The product continues to meet specifications and does not need to be returned. Customers with questions were encouraged to call their local Spectranetics Sales Representative or Spectranetics Customer Service Department. Customer Service can be reached by phone at 800-231-0978 (Option 2), by fax at 877-447-2022, or by email at customer.service@spnc.com. Customer Service is available Monday thru Friday, From 7AM-5PM MST.
Distribution Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands
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, Inc.
-
-