| Class 2 Device Recall Spectranetics TurboElite Laser Atherectomy Catheters | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MCW
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