Home / Recalls / Spectranetics Corporation / Z-0663-2017

Z-0663-2017 Class II Terminated

Recalled by Spectranetics Corporation — Colorado Springs, CO

FDA device recall Z-0663-2017 was initiated by Spectranetics Corporation on October 31, 2016 and is designated Class II. Reason for recall: Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised i… The recall status is terminated (terminated April 18, 2017). Affected quantity: 873 units.

Recall Details

Product Type
Devices
Report Date
December 7, 2016
Initiation Date
October 31, 2016
Termination Date
April 18, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
873 units

Product Description

Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Any use for procedures other than those indicated in the instructions is not recommended.

Reason for Recall

Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.

Distribution Pattern

Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.

Code Information

FMN16E11A; FMN16E18A; FMN16E25A; FMN16F01A; FMN16F08A; FMN16F15A FMN16F22A; FMN16G13A; FMN16G19A; FMN16G25A; FMN16H04A; FMN16H23A; FMN16J27A

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-0509-2024 Class II — Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spect (November 15, 2023)
  • 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)

FDA data resources