Home / Recalls / Spectranetics Corporation / Z-0509-2024

Z-0509-2024 Class II Ongoing

Recalled by Spectranetics Corporation — Colorado Springs, CO

Recall Details

Product Type
Devices
Report Date
December 20, 2023
Initiation Date
November 15, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,239 catheters

Product Description

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.

Reason for Recall

Incorrect product labeling. Exterior product box label does not match internal pouch label.

Distribution Pattern

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

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

Other recalls by Spectranetics Corporation

  • Z-1070-2025 Class I — Intact Vascular Tack Endovascular System, to treat vascular dissections with Tac (January 10, 2025)
  • Z-0680-2025 Class II — Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Des (November 25, 2024)
  • Z-0221-2023 Class II — Philips Laser System, REF: LAS-100. Used in minimally invasive interventional p (October 14, 2022)
  • Z-1351-2022 Class II — Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent (June 1, 2022)
  • Z-2143-2020 Class II — Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewir (March 31, 2020)
  • Z-0576-2020 Class II — Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter (December 7, 2018)
  • Z-3106-2017 Class I — Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guide (August 7, 2017)
  • Z-2863-2017 Class II — Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange C (June 6, 2017)
  • Z-0662-2017 Class II — ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, (October 31, 2016)
  • Z-0663-2017 Class II — Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the supe (October 31, 2016)