Class 2 Device Recall TurboElite Laser Atherectomy Catheter

• Date Initiated by Firm: November 15, 2023
• Date Posted: December 08, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0509-2024
• Recall Event ID: 93373
• 510(K)Number: K170059
• Product Classification: Catheter, peripheral, atherectomy - Product Code MCW
• Product: Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159; ; Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006; ; Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159; ; Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152; ; The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of; infrainguinal stenoses and occlusions in humans.
• Code Information: Model Number: 420-159 UDI code: 01)00813132024734(17)250614(10)FAZ23F06A Lot Number: FBH23F02A Model Number: 420-006 UDI code: (01)00813132024758(17)250622(10)FBA23F09A Lot Number: FBA23F09A Model Number: 414-159 UDI code: (01)00813132024727(17)250621(10)FBF23F05B Lot Number: FBF23F05B Model Number: 417-152 UDI code: (01)00813132024765(17)250623(10)FBH23F02A Lot Number: FAZ23F06A
• Recalling Firm/ Manufacturer: Spectranetics Corporation; 9965 Federal Dr; Colorado Springs CO 80921-3822
• For Additional Information Contact: Michelle Thompson; 425-908-2642
• Manufacturer Reason for Recall: Incorrect product labeling. Exterior product box label does not match internal pouch label.
• FDA Determined Cause: Packaging process control
• Action: On 11/15/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via US Postal Service Certified Mail to customers informing them that as a result of 3 complaints received the firm became aware that exterior box labels were incorrectly labeled and did not match the interior product pouch label. Customers are instructed to: -Immediately check their product inventory and quarantine any potentially affected devices from the affected lots. -Do not open or use any products that have been identified with their inventory -Complete and return the Response Form within 30 days so that Philips can initiate the return and replacement process free of charge (based upon the completed Response Form) -Circulate the notice to all users and/or to any organization where the potentially affected devices may have been transferred -Send completed Response Forms via email to igtdc.r@philips.com For questions or further assistance, contact local Philips representative or Philips Image Guided Therapy Devices Customer Service at 1-800-231-0978, option 2.
• Quantity in Commerce: 1,239 catheters
• Distribution: U.S Nationwide - Worldwide Distribution: US Distribution: AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, and WA Foreign Distribution: Germany, Italy, Poland and Spain
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MCW and Original Applicant = Spectranetics, Inc.