Recall Z-2863-2017 ยท MCW Catheter, Peripheral, Atherectomy
Spectranetics Corporation
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
| Date | Jul 14, 2017 (initiated Jun 6, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Spectranetics sent a Field Safety Notice letter via certified mail on June 7, 2017, to all customers who have ordered the affected model numbers since 23May2016 reiterating the risks associated with off-label use of the device (i.e., not activating the laser within a stent and not until all contrast media is flushed from the treatment area). The product continues to meet specifications and does not need to be returned. Customers with questions were encouraged to call their local Spectranetics Sales Representative or Spectranetics Customer Service Department. Customer Service can be reach |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170059 | Spectranetics Turbo-Elite Laser Atherectomy Catheters Spectranetics, Inc., Apr 7, 2017 |