Spectranetics Turbo-Elite Catheters Recall: Marker Band May Become Loose During Off-Label
Spectranetics recalls Turbo-Elite Laser Atherectomy Catheters with potential for marker band to become loose during off-label use. Affected models include 414-159 (1.4mm), 417-156 (1.7mm), and 420-159 (2.0mm).
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Spectranetics is recalling three specific laser atherectomy catheter models due to a risk that a marker band at the tip could become loose during off-label use. This could lead to the catheter not functioning properly during procedures, potentially causing complications. Read more at govinfonow.com/recall/73942-spectranetics-turbo-elite-catheters-recall-marker-band-may-become-loose.
Source Summary by GovInfoNow · govinfonow.com/recall/73942-spectranetics-turbo-elite-catheters-recall-marker-band-may-become-loose · Updated September 23, 2026 · FDA enforcement record: FDA #Z-2863-2017
Cite this page
“Spectranetics Turbo-Elite Catheters Recall: Marker Band May Become Loose During Off-Label.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73942-spectranetics-turbo-elite-catheters-recall-marker-band-may-become-loose. Based on FDA recall #Z-2863-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2863-2017%22&limit=1).
Why it’s dangerous
The marker band at the tip of the catheter can become loose when used in off-label applications. This may cause the catheter to malfunction during procedures, potentially leading to complications if the device is not properly secured.
Who’s affected
Healthcare professionals using these catheters for peripheral artery treatments are most at risk. Patients receiving off-label procedures with these devices may also be affected.
How to tell if you have this one
Check for model numbers 414-159 (1.4mm diameter), 417-156 (1.7mm), or 420-159 (2.0mm) on the catheter packaging or device. These models were sold for peripheral artery treatments.
- Brand
Spectranetics- Category
Medical device
What to do — step by step
Check Model Number
Identify the model number on the catheter to confirm if it is one of the affected models: 414-159, 417-156, or 420-159.
Where it went and when
Where it was distributed
Distributed in 39 states and Puerto Rico, and outside the U.S.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 4.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these catheters?
No specific stop-use instruction is provided; the recall focuses on off-label use, so users should follow proper procedures and check model numbers.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2863-2017 (June 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2863-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.