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Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon le...

FDA Recall #Z-0576-2020 — Class II — December 7, 2018

Recall #Z-0576-2020 Date: December 7, 2018 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

The incorrect outer carton box was used for the product.

Recalling Firm

Spectranetics Corporation — Fremont, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

3 catheters

Distribution

Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.

Code Information

AngioSculpt PTCA lot #G18090030.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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