medical Class II Updated 2019-12-04

Spectranetics Corporation recalls Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, bal

Recalled 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.


Hazard / Issue

The incorrect outer carton box was used for the product.

Issued by

FDA

Affected States: IA, MI, NJ
Lot/Code Info: AngioSculpt PTCA lot #G18090030.
View official government recall

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