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
FDA Recall Z-2863-2017 · Posted 2017-07-14
Recalling FirmSpectranetics Corporation
Recall StatusTerminated
Product CodeMCW
Date Initiated2017-06-06
Date Terminated2021-07-08
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.
Firm 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 reached by phone at 800-231-0978 (Option 2), by fax at 877-447-2022, or by email at [email protected]. Customer Service is available Monday thru Friday, From 7AM-5PM MST.
Root Cause
Device Design
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.