Recall Z-0758-2016
Spectranetics Corp. · initiated January 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot CMP15J28A
Reason for recall
The product is labeled with an expiration date that is past its shelf life.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-0758-2016
- Initiated
- January 15, 2016
- Posted by FDA
- February 5, 2016
- Terminated
- March 2, 2017
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 8 units
- Distribution
- Nationwide distribution to Florida, North Carolina and Pennsylvania.
- Recalling firm
- Spectranetics Corp., Colorado Springs, CO