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Class 2 Device Recall TurboPower |
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Date Initiated by Firm |
January 15, 2016 |
Date Posted |
February 05, 2016 |
Recall Status1 |
Terminated 3 on March 02, 2017 |
Recall Number |
Z-0758-2016 |
Recall Event ID |
73098 |
510(K)Number |
K152181
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Product Classification |
Catheter, peripheral, atherectomy - Product Code MCW
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Product |
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser System and is a Type CF device, Defibrillation proof. Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, with adjunctive Percutaneous Transluminal Angioplasty (PTA). Turbo-Power is used to directionally ablate infrainguinal concentric and eccentric lesions in vessels that are 3.5 mm or greater in diameter. The device is comprised of three parts: the working length of the catheter shaft (also the applied part), the motor drive unit (MDU), and the proximal laser shaft which connects the catheter fiber optics to the CVX-300" Excimer Laser System.
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Code Information |
Lot CMP15J28A |
Recalling Firm/ Manufacturer |
Spectranetics Corp. 9965 Federal Dr Colorado Springs CO 80921-3617
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For Additional Information Contact |
719-447-2318
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Manufacturer Reason for Recall |
The product is labeled with an expiration date that is past its shelf life.
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FDA Determined Cause 2 |
Error in labeling |
Action |
Spectranectics sent a Medical Device Field Action letter dated January 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and set aside the affected product and contact Customer Service at 1-800-231-0978 to arrange a product exchange. Customers were asked to document the return on the enclosed Field Action Acknowledgement and Receipt Form. Customers with additional questions were instructed to contact their local Spectranetics sales representative.
For questions regarding this recall call 719-447-2318. |
Quantity in Commerce |
8 units |
Distribution |
Nationwide distribution to Florida, North Carolina and Pennsylvania. |
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 and Original Applicant = SPECTRANETICS, INC.
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