Spectranetics Corporation 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Spectranetics Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Spectranetics Corporation is recalling Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite L due to Incorrect product labeling. Exterior product box label does not match internal pouch label.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect product labeling. Exterior product box label does not match internal pouch label.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026