Reported Aug 9, 2017 · Terminated
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in…
Spectranetics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectranetics Corporation · 9965 Federal Drive · Colorado Springs, CO · 80921-3617
Is this the product you have?
- Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
- Lot codes and dates
- Model Number 414-159 Catheter Diameter 1.4mm, Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm.
- Amount recalled
- N/A
Where it was sold
Why it was recalled
Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
This product could cause temporary or reversible health problems — stop using it.
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