Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Recalled by Spectranetics Corporation Due to Incorrect product labeling. Exterior product box label does...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Spectranetics Corporation directly.
Affected Products
Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.7 OTW REF 417-152 The Turbo-Elite devices are indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions in humans.
Quantity: 1,239 catheters
Why Was This Recalled?
Incorrect product labeling. Exterior product box label does not match internal pouch label.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Spectranetics Corporation
Spectranetics Corporation has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report