Spectranetics Corporation
Colorado Springs, CO
This page shows every FDA and USDA recall linked to Spectranetics Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
18
Total Recalls
2007
First Recall
2025
Most Recent
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angiopl...
Feb 14, 2025
· Device
Open, Classified
Turbo Elite Laser Atherectomy Catheter
Model Number / UDI-DI code / Product Description
414-151 / 989930000531...
Dec 16, 2024
· Device
Open, Classified
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159
Spectranetics Turbo-Elite Laser Ather...
Dec 8, 2023
· Device
Open, Classified
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovas...
Nov 11, 2022
· Device
Open, Classified
Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 V...
Jun 1, 2022
· Device
Open, Classified
Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Work...
Mar 31, 2020
· Device
Terminated
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Wo...
Aug 26, 2017
· Device
Terminated
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters
Device is indicated...
Jul 14, 2017
· Device
Terminated
Bridge Occlusion Balloon. Model: 590-001
Temporary vessel occlusion of the superior vena cava in applications...
Nov 28, 2016
· Device
Terminated
Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-1...
Nov 28, 2016
· Device
Terminated
ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009
The...
Nov 28, 2016
· Device
Terminated
Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, Sterile EO, Spectranetics Corporation, 96...
Aug 4, 2011
· Device
Terminated
Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96...
Aug 4, 2011
· Device
Terminated
Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for e...
Aug 9, 2010
· Device
Terminated
Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer.
Jun 1, 2009
· Device
Terminated
Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufact...
Feb 11, 2009
· Device
Terminated
Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314...
Jan 30, 2009
· Device
Terminated
Spectranetics Quick-Cross Support Catheters, .035in x 90cm, REF#: 518-036, Sterile, Manufactured by: Spectrane...
Feb 5, 2008
· Device
Terminated