Spectranetics Corporation: Medical Device Recall in 2017 - (Recall #: Z-2863-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 6, 2017

Date Posted: August 9, 2017

Recall Number: Z-2863-2017

Event ID: 77474

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

Code Information:

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.

Distribution Pattern:

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated