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Spectranetics Corporation recalls Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-251
Recalled December 4, 2019 · FDA recall Z-0576-2020 · Spectranetics
Hazard
The incorrect outer carton box was used for the product. · FDA Class II
Units
3 catheters
Sold at
Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.
Description
The incorrect outer carton box was used for the product.
Product
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.
Manufacturer(s)
Spectranetics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →