Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter Recalled by Spectranetics Corporation Due to The incorrect outer carton box was used for...
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 AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
Quantity: 3 catheters
Why Was This Recalled?
The incorrect outer carton box was used for the product.
Where Was This Sold?
This product was distributed to 3 states: IA, MI, NJ
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